Attachment B - 60 Day FRN 0920-0932

Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Notices
ACTION: Notification of Single Source
Cooperative Agreement Award for the
Pasteur Foundation for Building and
Strengthening Core Capacities for
Influenza Preparedness and Response in
Support of International Health
Regulations (2005) Implementation in
Selected Countries in Sub-Saharan
Africa and Southeast Asia. CFDA#:
93.019
STATUTORY AUTHORITY: Sections 301,
307, 1701 and 2811 of the Public Health
Service Act, 42 U.S.C. 241, 242l, 300u,
300hh–10.
AMOUNT OF SINGLE SOURCE AWARD:
$1,800,000.
PROJECT PERIOD: September 30, 2011 to
September 29, 2014.
SUMMARY: In FY2011, HHS/ASPR/OPP
plans to provide a Single Source
Cooperative Agreement Award to the
Pasteur Foundation to build and
strengthen core capacities for influenza
preparedness and response in support of
International Health Regulations (2005)
implementation in Sub-Saharan Africa
and Southeast Asia.
ASPR, in close coordination with the
HHS Centers for Disease Control and
Prevention (CDC), will collaborate with
the Pasteur Institute and Pasteur
Institute affiliates in Cameroon, Central
African Republic, and Senegal in Africa,
and Cambodia in Asia to develop and
implement activities for preparedness
and response for pandemic influenza
with applicability to other emerging
respiratory infections and public health
threats in general. The project will focus
on building upon existing routine health
systems to further develop IHR (2005)
core capacities including
communication (IHR National Focal
Point communication), workforce
development, and surveillance and
laboratory diagnostics. This work will
be performed in the context of Article
44 of the IHR (2005), which directs State
Parties to collaborate with each other to
detect, assess, and respond to events,
and to develop, strengthen, and
maintain core public health capacities
for surveillance and response.

emcdonald on DSK2BSOYB1PROD with NOTICES

Single Source Justification
In the recent past, ASPR and Pasteur
Institute collaborated on developing
epidemiological surveillance capacity
for influenza-like illness (ILI) in five
countries in Africa and three countries
in Asia as the basis for developing the
capacities to detect influenza viruses
with epidemic or pandemic potential.
As a result of this project and the
collaboration with other international
partners, eighty surveillance sites were
established among the eight countries,

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the laboratories in Cameroon and
Cambodia became National Reference
Laboratories for avian influenza, and all
eight laboratories in the host-countries
became WHO National Influenza
Centers.
In Southeast Asia, the International
Network of Pasteur Institutes is
strategically positioned to study the
natural history of Highly Pathogenic
Avian Influenza (HPAI H5N1).
Cambodia and its affiliated Pasteur
Institute are important partners in the
region that can act as a hub for training
and sharing of technical expertise as its
National Influenza Center can identify
and isolate HPAI H5N1 strains and has
experience in Influenza-Like Illness (ILI)
and Severe Acute Respiratory Infections
(SARI) surveillance.
In Sub-Saharan Africa, Cameroon has
built a surveillance system and the
Centre Pasteur of Cameroun under the
Ministry of Health has been designated
by WHO as a National Influenza Center.
Moreover, the Centre Pasteur du
Cameroun is also the National IHR
Focal Point, making it a key partner for
IHR (2005) implementation. The Pasteur
Institute of Bangui in the Central
African Republic (CAR) is recognized by
WHO as a National Influenza Center.
This is the only organization capable of
performing influenza diagnostics in the
country, which was able to detect the
first case of H1N1 in 2010. This
recognition will be leveraged to further
strengthen and interlink the current
surveillance network for highly
pathogenic avian influenza H5N1. A
solid partnership between Cameroon
and CAR is particularly important as
this is a region in Sub-Saharan Africa
where the virus has been detected. In
Senegal, the Pasteur Institute of Dakar
has set up the influenza surveillance
sentinel system, is reporting to the
Ministry of Health, and is hosting the
National Influenza Center. Senegal has a
leading role in the West African region
on influenza, and with its involvement
in regional CDC’s Field Epidemiology
Training Program, could become an
important leader with regard to IHR
(2005) implementation. In addition,
Senegal is the one of the two countries
in Africa that currently has the potential
to develop influenza vaccine
manufacturing technology in the shortto medium-term, if supported by
international partners, including ASPR.
In making this award, ASPR will
capitalize on the Pasteur Institute
International Network and its access to
francophone countries in Africa and
with a strong French influence in Asia.
Based on the lessons learned from
previous collaborations, this new
investment will allow HHS to contribute

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to build international capacity in
collaboration with a prestigious
international partner by sharing
experiences, strategies, and best
practices, and other technical resources
in helping developing countries
improve their capabilities for pandemic
influenza and implement IHR core
capacities.
In summary, the Pasteur Institute’s
strong collaborative relationships with
foreign governments, programmatic
support, and familiarity with hostcountry involvement in influenza
preparedness will be critical for the
viability of this cooperative agreement.
This collaboration will support HHS
efforts to continue building capacity
abroad with the ultimate intent of
detecting, stopping, slowing or
otherwise limiting the spread of a
pandemic to the United States,
ultimately enhancing the health security
of the American population.
ADDITIONAL INFORMATION: The agency
program contact is Dr. Maria Julia
Marinissen, who can be contacted at
202–205–4214 or
[email protected].
Dated: August 5, 2011.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2011–20312 Filed 8–9–11; 8:45 am]
BILLING CODE 4150–37–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-11–11JQ]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Daniel Holcomb, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an e-mail to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including

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49488

Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Notices

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) 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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Data Collection for Evaluation of
Education, Communication, and
Training Activities—New—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Division
of Global Migration and Quarantine
(DGMQ), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) Division of Global
Migration and Quarantine (DGMQ) is
requesting a three year approval for a
generic clearance to conduct evaluation
research in order to plan and implement
health communication, education, and
training activities to improve health and
prevent the spread of disease. These
activities include communicating with
international travelers and other mobile
populations, training healthcare
providers, and educating public health
departments and other federal partners.
The information collection for which
approval is sought is in accordance with
DGMQ’s mission to reduce morbidity
and mortality among immigrants,
refugees, travelers, expatriates, and
other globally mobile populations, and
to prevent the introduction,

transmission, or spread of
communicable diseases from foreign
countries into the United States. This
mission is supported by delegated legal
authorities.
First, section 361 of the Public Health
Service (PHS) Act (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services (HHS) to make and
enforce regulations necessary to prevent
the introduction, transmission or spread
of communicable diseases from foreign
countries or possessions into the United
States and from one state or possession
into any other state or possession. These
regulations are codified in 42 Code of
Federal Regulations (CFR) parts 70 and
71.
In addition, the Secretary of Health
and Human Services also has the legal
authority to establish regulations
outlining the requirements for the
medical examination of aliens before
they may be admitted into the United
States. This authority is provided under
Section 212(a)(1)(A) of the Immigration
and Nationality Act (8 U.S.C.
1182(a)(1)(A)) and Section 325 of the
Public Health Service Act. These
regulations are codified in 42 CFR part
34, which establish requirements that
determine whether aliens can be
admitted into the United States.
Successful implementation of
DGMQ’s regulatory authority and public
health mission as outlined above
requires a variety of communication,
training and educational activities
involving staff, partners, mobile
populations and the general public.
DGMQ conducts these activities in order
to inform, educate and empower key
audiences with respect to important
public health issues.
This generic OMB clearance will
allow DGMQ to quickly collect
information about the knowledge,

attitudes, and behaviors of key
audiences (such as refugees,
immigrants, migrants, international
travelers, travel industry partners,
healthcare providers, non-profit
agencies, customs brokers and
forwarders, schools, state and local
health departments) to help improve
and inform these activities during both
routine and emergency public health
events. This generic OMB clearance will
help DGMQ continue to refine these
efforts in a timely manner, and will be
especially valuable for communication
activities that must occur quickly in
response to public health emergencies.
DGMQ staff will use a variety of data
collection methods for this proposed
project: Interviews, focus groups, group
discussions, surveys, and pre-post tests.
Depending on the research questions
and audiences involved, data may be
gathered in-person, by telephone,
online, or using some combination of
these formats. Data may be collected in
quantitative and/or qualitative forms.
Numerous audience variables will be
assessed under the auspices of this
generic OMB clearance. These include,
but are not limited to, knowledge,
attitudes, beliefs, behavioral intentions,
practices, behaviors, skills, self-efficacy,
and information needs and sources.
Insights gained from evaluation research
will assist in the development,
refinement, implementation, and
demonstration of outcomes and impact
of communication, education, and
training activities.
DGMQ estimates that 22,166 hours
will be involved in evaluation research
activities each year. The information
being collected will not impose a cost
burden on the respondents beyond that
associated with their time to provide the
required data.

emcdonald on DSK2BSOYB1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Form name

General Public/Healthcare Professionals Focus
groups.
General Public/Healthcare Professionals Interviews.
General Public/Healthcare Professionals Large
Group Discussions.
General Public/Healthcare Professionals Surveys
General Public/Healthcare Professionals Pre/post
tests.

Screening form .....................
Focus Groups .......................
Screening Form ....................
Interviews ..............................
Screening Forms ..................
Large Group Discussion .......
Screening Forms ..................
Surveys .................................
Screening Forms ..................
Pre/Post Tests ......................

3,000
1,500
2,000
1,000
2,000
1,000
15,000
7,500
15,000
7,500

1
1
1
1
1
1
1
1
1
1

10/60
90/60
10/60
60/60
10/60
90/60
10/60
45/60
10/60
45/60

500
2,250
333
1,000
333
1,500
2,500
5,625
2,500
5,625

Total ...............................................................

...............................................

......................

......................

......................

22,166

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Number of
respondents

Number of
responses
per
respondent

Type of
respondents

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Total burden
(in hours)

Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Notices
Dated: August 4, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–20343 Filed 8–9–11; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day-11–11JD]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Daniel Holcomb, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an e-mail to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (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. Written comments should
be received within 60 days of this
notice.

emcdonald on DSK2BSOYB1PROD with NOTICES

Proposed Project
Evaluation of Dating Matters:
Strategies To Promote Healthy Teen
RelationshipsTM—New—National
Center for Injury Prevention and
Control—Centers for Disease Control
and Prevention
Background and Brief Description
Dating Matters: Strategies To Promote
Healthy Teen RelationshipsTM is the
Centers for Disease Control and
Prevention’s new teen dating violence
prevention initiative.

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Recently, efforts to prevent teen
dating violence have grown, particularly
in schools, among policymakers, and
among sexual violence and domestic
violence coalitions. Now many states
and communities also are working to
stop teen dating violence. However,
these activities vary greatly in quality
and effectiveness. To address the gaps,
CDC has developed Dating Matters, a
comprehensive teen dating violence
prevention program based on the
current evidence about what works in
prevention.
Dating Matters focuses on high-risk,
urban communities where participants
include: middle school students age 11
to 14 years; middle school parents;
brand ambassadors; educators; school
leadership; program implementers;
community representatives; and local
health department representatives in
four high-risk urban communities. The
primary goal of the current proposal is
to conduct an outcome and
implementation evaluation of Dating
Matters in four metropolitan cities to
determine its feasibility, cost, and
effectiveness. Within each city 12
schools will implement the two models
of teen dating violence prevention (48
schools total over 4 sites). Our burden
estimates are based on each school
having 600 students, with 200 students
per grade (6th, 7th, and 8th grades).
Therefore the sampling frame for this
data collection is 48,000 for the three
years of data collection covered by this
OMB package (5 cohorts of 200 students
each in 48 schools; 5 x 200 x 48). The
5 cohorts will be students who are in
6th, 7th and 8th grade in year 1 of data
collection, students in 6th grade in years
2 and 3 of data collection. That means
the sampling frame for parents, given
that we would only include one parent
per student, is also 48,000 for the three
years of data collection covered by this
package. Based on our research and
consultation with middle schools, most
schools with approximately 600
students have approximately 40 staff. If
we assume 40 educators per school, the
sampling frame for the educator sample
is 1,920. The following are explanations
of estimated burden by respondent.
Students: We will use random
selection to identify a subsample of
students from each cohort from each
school to participate in the evaluation.
We estimate that we will enroll 40
students per cohort per school, for a
total of 1,920 students per grade and
9,600 for the entire sample of 5 cohorts
covered under this OMB package.
Parents: We will recruit all parents
participating in the parent curricula and
select an equal number of parents from
the standard of care schools to serve as

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a matched comparison group. We will
enroll 40 parents per grade per school,
with 1920 parents per grade, so 5,760
parents per year.
Educators: We expect that 85% of all
educators will participate. With an
estimated 40 educators per 48 schools
(1920 total), 85% is 1632 educators.
School data extractors: We will
recruit one data extractor per each
school (48 extractors total) to extract
school data to be used in conjunction
with the outcome data for the students.
Individual level school data will only be
collected for students participating in
the evaluation, so this data will reflect
the same sampling frame as the student
survey data.
School leadership: We will recruit
one school leadership (e.g., principal,
vice principal) per 48 schools, the
number of respondents will be 48.
Local Health Department
representative: We will recruit four local
health department representatives
working on the initiative per
community, the number of respondents
will be 16.
Parent Program Manager: With a
maximum of one parent program
manager per community, the number of
program manager respondents will be 4.
Community Representative: We will
recruit 10 community representatives
per site, the number of respondents will
be 40.
Parent Curricula Implementers: Each
school/neighborhood implementing the
comprehensive approach will have one
male and one female parent
implementing the parent programs with
six comprehensive school/neighborhood
clusters per community plus one
additional pair per site (will fill-in as
needed), respondents will be (2x7x4) 56
implementers.
Student Curricula Implementers: We
will have six student curricula
implementers per school that will be
completing fidelity instruments, the
total number of respondents will be 288.
Safe Dates Implementers: We will
have 3 Safe Dates implementers per the
48 schools, who will implement the 8th
grade Safe Dates program, the number of
respondents for the Safe Dates
implementer survey will be 144.
Brand Ambassadors: The Brand
Ambassador Implementation Survey
will be provided to each brand
ambassador in each community. With a
maximum of 20 brand ambassadors per
community, the feedback form will be
collected from a total of 80 brand
ambassadors.
Communications Implementers
(‘‘Brand Ambassador Coordinators’’):
The Communications Campaign
Tracking form will be provided to each

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