Attachment B - Federal Register Notice

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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices

Secretary of Health and Human Services
approved for the Council charter to be
renewed. Renewal of the PACHA
charter provides authorization for the
Council to operate until July 27, 2011.
A copy of the Council charter is
available on the PACHA Web site at
http://www.pacha.gov. A copy of the
Council charter also can be obtained by
accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
Web site address for the FACA database
is http://fido.gov/facadatabase.
Dated: July 28, 2009.
Christopher H. Bates,
Interim Executive Director, Presidential
Advisory Council on HIV/AIDS.
[FR Doc. E9–18572 Filed 8–3–09; 8:45 am]

displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0635. The
approval expires on May 31, 2012. A
copy of the supporting statement for this
information collection is available on
the Internet at http://www.reginfo.gov/
public/do/PRAMain.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18532 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

BILLING CODE 4150–43–P

[60Day–09–09CH]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations

Food and Drug Administration
[Docket No. FDA–2007–D–0372]

Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Adverse Event Reporting and
Recordkeeping for Dietary
Supplements as Required by the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:

Food and Drug Administration,

HHS.

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ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 15, 2008
(73 FR 53252), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it

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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 Maryam I. Daneshvar,
CDC Acting 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.
Proposed Project
A Controlled Evaluation of Expect
Respect Support Groups (ERSG):
Preventing and Interrupting Teen Dating
Violence among At-Risk Middle and

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High School Students—New—National
Center for Injury Prevention and Control
(NCIPC), Division of Violence
Prevention (DVP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The prevalence and consequences of
teen dating violence make it a public
health concern that requires early and
effective prevention. To date, only three
prevention strategies—Safe Dates, the
Youth Relationships Project, and 4th
R—have demonstrated reductions in
dating violence behaviors in rigorous,
controlled evaluations. In order to
protect young people and build an
evidence-base of effective prevention
strategies, evaluation of additional
programs is needed, including those
programs currently in the field. Expect
Respect Support Groups (provided by
SafePlace) are currently in use in the
Austin Independent School District and
demonstrated promising results in an
uncontrolled program evaluation,
suggesting a controlled evaluation is
warranted to more rigorously examine
program effects. The proposed study has
one primary aim and two exploratory
aims. The primary aim is to evaluate the
effectiveness of Expect Respect Support
Groups (ERSG) to prevent and reduce
teen dating violence and increase
healthy conflict resolution skills
reported by at-risk male and female
middle and high school students
compared to at-risk students in control
schools who do not receive ERSG. The
exploratory aims are: (1) To evaluate
whether or not the effectiveness of
ERSG is enhanced by the presence of a
universal, school-wide prevention
program, and (2) To examine
moderators and mediators of targeted
and universal teen dating violence
interventions, such as biological sex and
history of abuse at intake.
The proposed evaluation will use a
quasi-experimental/non-randomized
design in which a convenience sample
of participants in schools receiving
targeted prevention services are
compared to students in control schools
in which no dating violence prevention
services are available. Control schools
will be selected that have characteristics
(e.g., risk status, socio-economic status)
similar to the Austin Independent
School District intervention schools.
Based on past, uncontrolled program
evaluation of Expect Respect Support
groups, we anticipate that in the Austin
Independent School District and
neighboring district(s), 800 students will
undergo an intake assessment, of whom
600 will be eligible for Expect Respect
Support groups and will complete the
baseline survey. We expect 400 students

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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
to complete the survey and two-followup assessments. Therefore, over three
years 2400 students will undergo an
intake assessment, of whom we will

recruit 1800 students into the study (300
per year from intervention schools and
300 per year from control schools), of

whom we anticipate 1200 will have
complete data.
There is no cost to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent

Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Middle and High School Students ............

Intake assessment ...................................
Baseline Survey .......................................
Completion Survey ...................................
Follow-up Survey 1 ..................................
Follow-up Survey 2 ..................................

800
600
400
400
400

1
1
1
1
1

15/60
1
1
1
1

200
600
400
400
400

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

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

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

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

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

2000

Dated: July 24, 2009.
Marilyn S Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–18604 Filed 8–3–09; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the OMB for review under
the Paperwork Reduction Act of 1995:

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Number of
respondents

Form name

Proposed Project: Intervention Trials
To Retain HIV-Positive Patients in
Medical Care: (New)
The purpose of this project is to
develop, implement, and test the
efficacy of an intervention designed to
increase client appointment attendance
among patients at risk of missing
scheduled appointments at HIV clinics.
This project is a collaboration between
the Centers for Disease Control and
Prevention (CDC), the Health Resources
and Services Administration (HRSA),
and six university-affiliated HIV clinics
in the United States. The proposed
intervention will be implemented in
two phases. Phase 1 is a clinic-wide

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intervention that includes the following
components: a theme slogan for the
intervention, brochures, posters with
messages to patients, brief verbal
retention in care messages from
providers to patients, buttons printed
with the theme of the intervention worn
by providers, and appointment
reminder cards with information on
how to cancel appointments. All clinic
patients will receive the Phase 1
intervention. Phase 2 of the project is a
three-arm randomized trial in which
300 patients in each of the six
participating sites will be enrolled and
randomly assigned to one of three study
arms. In Arm 1 (control arm), patients
(n=100) will receive the clinic-wide
intervention only. Patients (n=100)
assigned to Arm 2 (intervention arm)
will continue to receive the clinic-wide
intervention plus a comprehensive
client-centered intervention from two
trained interventionists. The remaining
100 patients will be assigned to Arm 3
and will receive the clinic-wide
intervention plus a brief client-centered
intervention.
The efficacy of the intervention will
be assessed through data collection
efforts tailored to each phase of the
intervention. Phase 1 uses a pre-post
comparison of clinic attendance rates
before and during a clinic-wide
intervention. Specifically, in Phase 1,
the attendance rate for HIV primary care
is currently being assessed via
electronic medical records during the
12-month period before the clinic-wide
intervention begins. This preintervention assessment is being
collected for all patients who had at
least one HIV primary care visit at the
clinic during the preceding 12 months.
This cohort of patients will be
reassessed via electronic medical
records during the 12-month
intervention period. In addition,
provider surveys will be administered

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quarterly during Phase 1 and semiannually during Phase 2 to obtain
information from primary care providers
(MD, DO, nurse practitioner, physician
assistant) about whether they talked to
their patients about the importance of
regular care. Patient exit interviews will
be administered every other month to
assess patient exposure to the theme
slogan for the intervention and posters
with messages to patients as well as
receipt of brochures and brief verbal
retention in care messages from
clinicians and clinic staff that comprise
the Phase 1 intervention.
In Phase 2, participants will be
enrolled over a period of 4–9 months to
allow flexibility for faster or slower
enrollment in the clinics. It is
anticipated that most clinics will
complete their enrollment in
approximately 6 months. On a daily
basis, clinic staff or the study
coordinator will generate a list of
patients who meet eligibility criteria
based on attendance history. The list
will be given to the study coordinator
who will approach patients to ask about
their interest in being screened for
eligibility in the study. When patients
agree to be screened for eligibility, the
study coordinator will administer an
eligibility screener. Patients who are
found to be eligible will be enrolled in
the project and all enrollees will
complete a baseline survey (that will
take approximately 30 minutes) before
being randomized to one of the two
intervention arms or the control arm. No
follow-up surveys will be collected. The
survey will be administered in a private
setting at the clinic using Audio
Computer-Assisted Self-Interview
(ACASI) in which respondents can read
and listen via earphones to survey
questions presented on the computer
screen and respond directly into the
computer.

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