Agency Information Collection Activities: Submission for OMB Review; Comment Request, 44340-44341 [2011-18759]
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Federal Register / Vol. 76, No. 142 / Monday, July 25, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
with the RAC Chair and one or more
RAC members as needed. This
consultation is complete. However, in
the interest of soliciting broad public
input, OBA is submitting this action for
public comment and will finalize the
changes after reviewing any comments.
DATES: The public is encouraged to
submit written comments on this minor
action. Comments may be submitted to
the OBA in paper or electronic form at
the OBA mailing, fax, and e-mail
addresses shown below under the
heading FOR FURTHER INFORMATION
CONTACT. The NIH will consider all
comments submitted by September 9,
2011. All written comments received in
response to this notice will be available
for public inspection at the NIH OBA
office, 6705 Rockledge Drive, Suite 750,
Bethesda, MD 20817–7985, weekdays
between the hours of 8:30 a.m. and 5
p.m.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional information about these
changes, please contact OBA by e-mail
at oba@od.nih.gov, telephone (301–496–
9838), or mail to the Office of
Biotechnology Activities, National
Institutes of Health, 6705 Rockledge
Drive, Suite 750, Bethesda, Maryland
20892–7985.
Background: Appendix B of the NIH
Guidelines is a list of biological agents
that are classified into risk groups on
the basis of their ability to cause disease
in healthy adults and the availability of
preventive or therapeutic interventions.
Agents listed in Appendix B have been
classified into one of four risk groups:
• RG1 agents are those that are not
associated with disease in healthy adult
humans;
• RG2 agents are those that are
associated with human disease which is
rarely serious and for which preventive
or therapeutic interventions are often
available;
• RG3 agents are associated with
serious or lethal human disease for
which preventive or therapeutic
interventions may be available; and
• RG4 agents are those that are likely
to cause serious or lethal human disease
for which preventive or therapeutic
interventions are not usually available.
For the most part, the agents listed in
Appendix B are wild-type, fully
pathogenic strains. However, laboratory
research that is subject to the NIH
Guidelines frequently employs strains
that are attenuated. An attenuated strain
is not necessarily avirulent but generally
is less pathogenic than the wild-type
strain, and therefore the biosafety risk
posed by research with an attenuated
strain is not necessarily equivalent to
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that posed by the wild-type strain. As
the RG of an agent is the starting point
for the risk assessment to determine
containment for research with that
agent, OBA is amending Appendix B to
provide more specific guidance for these
attenuated strains.
In addition to designating RGs for
several attenuated strains, four
additional changes will be made to
Appendix B. The classification of
attenuated strains of Vesicular
stomatitis virus will be clarified. West
Nile Virus (WNV) and Chikungunya
virus are currently not specifically listed
in the RG classification. WNV will now
be listed as a RG3 Flavivirus and
Chikungunya virus will be listed as a
RG3 Togavirus. In addition, the
coronavirus that is the causative agent
of severe acute respiratory syndrome
(SARS) will be listed as a RG3
coronavirus. All coronaviruses are
currently RG2 viruses. The BMBL
currently recommends BL3 containment
for research with these three viruses.
The following additions will be made
to Appendix B–II–A. Risk Group 2
(RG2)—Bacterial Agents Including
Chlamydia:
Coxiella burnetii, Nine Mile strain,
plaque purified, clone 4
*Francisella tularensis subspecies
novicida (also referred to as Francisella
novicida) strain, Utah112
*Francisella tularensis
subspeciesholartica LVS
*Francisella tularensis biovar
tularensis strain ATCC 6223 (also
known as strain B38)
Yersinia pestis pgm(¥) (lacking the
102 kb pigmentation locus)
Yersinia pestis lcr(¥) (lacking the LCR
plasmid).
The following footnote will be added
regarding research with attenuated
strains of Francisella:
*For research involving high
concentrations, BL3 practices should be
considered (See Appendix G–II–C–2).
The following changes/additions will
be made to Appendix B–II–D (RG2
Viruses) of the NIH Guidelines:
Alphaviruses (Togaviruses)—Group A
Arboviruses.
‘‘Venezuelan equine
encephalomyelitis vaccine strain
TC–83’’ will be changed to:
Venezuelan equine encephalomyelitis
vaccine strains TC–83 and V3526.
The following will be added to
Appendix B–II–D:
Alphaviruses (Togaviruses)—Group A
Arboviruses.
Add: Chikungunya vaccine strain
181/25.
Arenaviruses.
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Add: Junin virus candid #1 vaccine
strain.
Flaviviruses (Togaviruses)—Group B
Arboviruses.
Add: Japanese encephalitis virus
strain SA 14–14–2.
Rhabdoviruses.
‘‘Vesicular stomatitis virus—
laboratory adapted strains including
VSV–Indiana, San Juan, and
Glasgow’’ will be changed to:
Vesicular stomatitis virus non-exotic
strains: VSV–Indiana 1 serotype
strains (e.g. Glasgow, MuddSummers, Orsay, San Juan) and
VSV–New Jersey serotype strains
(e.g. Ogden, Hazelhurst).
The following additions will be made
to Appendix B–III–D (RG3 Viruses and
Prions) of the NIH Guidelines:
Add: Coronaviruses.
Add: SARS-associated coronavirus
(SARS–CoV).
Alphaviruses (Togaviruses)—Group A
Arboviruses.
Add: Chikungunya.
Flaviviruses (Togaviruses)—Group B
Arboviruses.
Add: West Nile Virus (WNV).
Dated: July 18, 2011.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology
Activities, National Institutes of Health.
[FR Doc. 2011–18726 Filed 7–22–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: The Safe Schools/Healthy
Students (SS/HS) Initiative National
Evaluation (OMB No. 0930–0297)—
Revision
SAMHSA’s Center for Mental Health
Services (CMHS) will conduct a study to
evaluate the relationships between
different grantee characteristics and
implementation strategies to outcomes
at the project, school, and student level.
Data collected by this study will
facilitate an examination of contextual
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25JYN1
44341
Federal Register / Vol. 76, No. 142 / Monday, July 25, 2011 / Notices
factors and inform those who hope to
improve the effectiveness of
partnerships and implementation efforts
under the grant and lead to improved
outcomes for communities, schools, and
students. The three agencies sponsoring
the SS/HS Initiative (the U.S.
Department of Health and Human
Services, the U.S. Department of
Education, and the U.S. Department of
Justice) may also choose to incorporate
aggregate results from collected data in
journal articles, scholarly presentations,
and congressional testimony referring to
the outcomes of the SS/HS grant
program.
Data collection activities involve the
administration of four separate surveys
(a Baseline Assessment Survey, a
Project-Level Survey, a School-Level
Survey, and a Staff School Climate
Survey) and a Site Visit Protocol for
individuals involved with the SS/HS
Initiative at the local grantee level.
Respondents will submit their responses
for all surveys via Qualtrics, a thirdparty, online Web-based survey
platform, except for the Site Visit
Protocol, which will be administered on
site with grantees.
The estimated burden for data
collection is 5,732 hours across a total
of 28,125 participants. Using median
hourly wage estimates reported by the
Bureau of Labor Statistics, May 2009
National Occupational Employment and
Wage Estimates, and a loading rate of
25%, the estimated total cost to
respondents is $207,343. A breakdown
of these estimates is presented in Table
1 below.
TABLE 1—ELEMENTS OF ANNUALIZED HOUR-COST BURDEN OF DATA COLLECTION *
Anticipated
number of respondents
Instrument description
Responses
per respondent
Average hours
per response
Total annual
hour burden
Site Visit Protocol ..........................................................................................
Baseline Assessment Survey ........................................................................
Partnership Inventory .....................................................................................
Project-Level Survey ......................................................................................
School-Level Survey ......................................................................................
Staff School Climate Survey ..........................................................................
100
25
400
100
2,300
25,200
1
1
1
1
1
1
9
.67
0.25
0.42
0.45
0.117
900
17
100
42
1,725
2,948
Total ........................................................................................................
28,125
........................
..........................
5,732
* Number of respondents based on an estimated annual average of 100 grantees. Baseline Assessment Survey administered only to grantees
in the 2011–2013 cohorts. School-Level Survey estimates based on an average of 23 schools per grant. Staff School Climate Survey estimates
based on 252 respondents per grantee. Average hours per response based on previous evaluation and pilot tests.
Written comments and
recommendations concerning the
proposed information collection should
be sent by August 24, 2011 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–7285.
Dated: July 18, 2011.
Elaine Parry,
Director, Office of Management, Technology
and Operations.
[FR Doc. 2011–18759 Filed 7–22–11; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jlentini on DSK4TPTVN1PROD with NOTICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
VerDate Mar<15>2010
16:15 Jul 22, 2011
Jkt 223001
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Assessment of the Underage
Drinking Prevention Education
Initiatives State/Territory Videos
Project—New
The Substance Abuse and Mental
Health Services Administration/Center
for Substance Abuse Prevention
(SAMHSA/CSAP) is requesting Office of
Management and Budget (OMB)
approval of three new data collection
instruments—
• State/Territory Video Contacts
Interview Form
• State/Territory Videos Project—
Dissemination Update Form
• Video Viewers Feedback Form
This new information collection is for
a process assessment of the Underage
Drinking Prevention Education
Initiatives State/Territory Videos project
to be conducted from 2011 through
2014. In 2007, four States participated
in a pilot study to produce videos
highlighting the underage drinking
(UAD) prevention efforts of the States.
Based upon the success of those videos
in showcasing the States’ UAD
prevention activities, 10 additional
States and 1 Territory were provided
funds to produce UAD prevention
videos in 2009. SAMHSA/CSAP intends
to support the production of the State/
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Territory UAD prevention videos
annually. Therefore, from 2010 through
2013, SAMHSA/CSAP will invite
approximately 45 additional States/
Territories to produce their own UAD
prevention video.
The information collected for the
assessment will be used by SAMHSA/
CSAP to (1) Ascertain whether the
videos produced under the State/
Territory Videos project are assisting
States and Territories in communicating
effectively about their underage
drinking prevention initiatives, goals,
and objectives; (2) document the
dissemination efforts of the videos; and
(3) enhance the technical assistance
(TA) that is provided by the video
production team in producing the
videos. This information collection is
being implemented under authority of
Section 501(d)(4) of the Public Health
Service Act (42 U.S.C. 290aa).
There are three phases to the process
assessment of the State/Territory Videos
project—(1) State/Territory video
contacts interviews, (2) dissemination
updates, and (3) video viewers feedback.
Phase I—State/Territory Video
Contacts Interviews—A member of the
assessment team will contact the
designated State/Territory point of
contact once the video is finalized. The
focus of the interview will be around
the State’s/Territory’s experience in
producing the UAD prevention video,
E:\FR\FM\25JYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 142 (Monday, July 25, 2011)]
[Notices]
[Pages 44340-44341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: The Safe Schools/Healthy Students (SS/HS) Initiative National
Evaluation (OMB No. 0930-0297)--Revision
SAMHSA's Center for Mental Health Services (CMHS) will conduct a
study to evaluate the relationships between different grantee
characteristics and implementation strategies to outcomes at the
project, school, and student level. Data collected by this study will
facilitate an examination of contextual
[[Page 44341]]
factors and inform those who hope to improve the effectiveness of
partnerships and implementation efforts under the grant and lead to
improved outcomes for communities, schools, and students. The three
agencies sponsoring the SS/HS Initiative (the U.S. Department of Health
and Human Services, the U.S. Department of Education, and the U.S.
Department of Justice) may also choose to incorporate aggregate results
from collected data in journal articles, scholarly presentations, and
congressional testimony referring to the outcomes of the SS/HS grant
program.
Data collection activities involve the administration of four
separate surveys (a Baseline Assessment Survey, a Project-Level Survey,
a School-Level Survey, and a Staff School Climate Survey) and a Site
Visit Protocol for individuals involved with the SS/HS Initiative at
the local grantee level. Respondents will submit their responses for
all surveys via Qualtrics, a third-party, online Web-based survey
platform, except for the Site Visit Protocol, which will be
administered on site with grantees.
The estimated burden for data collection is 5,732 hours across a
total of 28,125 participants. Using median hourly wage estimates
reported by the Bureau of Labor Statistics, May 2009 National
Occupational Employment and Wage Estimates, and a loading rate of 25%,
the estimated total cost to respondents is $207,343. A breakdown of
these estimates is presented in Table 1 below.
Table 1--Elements of Annualized Hour-Cost Burden of Data Collection *
----------------------------------------------------------------------------------------------------------------
Anticipated
Instrument description number of Responses per Average hours Total annual
respondents respondent per response hour burden
----------------------------------------------------------------------------------------------------------------
Site Visit Protocol............................. 100 1 9 900
Baseline Assessment Survey...................... 25 1 .67 17
Partnership Inventory........................... 400 1 0.25 100
Project-Level Survey............................ 100 1 0.42 42
School-Level Survey............................. 2,300 1 0.45 1,725
Staff School Climate Survey..................... 25,200 1 0.117 2,948
---------------------------------------------------------------
Total....................................... 28,125 .............. .............. 5,732
----------------------------------------------------------------------------------------------------------------
* Number of respondents based on an estimated annual average of 100 grantees. Baseline Assessment Survey
administered only to grantees in the 2011-2013 cohorts. School-Level Survey estimates based on an average of
23 schools per grant. Staff School Climate Survey estimates based on 252 respondents per grantee. Average
hours per response based on previous evaluation and pilot tests.
Written comments and recommendations concerning the proposed
information collection should be sent by August 24, 2011 to: SAMHSA
Desk Officer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service, respondents are encouraged to
submit comments by fax to: 202-395-7285.
Dated: July 18, 2011.
Elaine Parry,
Director, Office of Management, Technology and Operations.
[FR Doc. 2011-18759 Filed 7-22-11; 8:45 am]
BILLING CODE 4162-20-P
