Agency Information Collection Activities: Submission for OMB Review; Comment Request, 38635-38636 [E9-18524]
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38635
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
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hours)
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
...................................................................
....................
....................
....................
2000
Type of
respondent
Form name
Middle and High School Students ............
Total ...................................................
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
mstockstill on DSKH9S0YB1PROD with NOTICES
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:
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
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Total burden
(in hours)
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.
E:\FR\FM\04AUN1.SGM
04AUN1
38636
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
Participants randomly assigned into
the intervention arms will receive
comprehensive or brief interventional
services from two trained
interventionists. The interventions will
be delivered in face-to-face encounters
as well as over the telephone and the
first dose of the intervention will be
delivered on the day the participant is
enrolled into study. During the first
face-to-face encounter, an
interventionist will administer a
retention risk screener. This screener is
a clinical tool that will help identify
attitudes, barriers, and unmet needs that
might prevent a patient from staying in
care. The screener contains three
sections: (1) Attitudes and beliefs about
HIV care and treatment, (2) barriers to
consistent clinic attendance (e.g.,
transportation, child care, housing
instability, scheduling problems, and
lack of social support), and (3) recent
drug/alcohol use and mental health. The
information obtained from the risk
screener will be used to tailor the
interventions to each individual
patient’s needs. Because a patient’s
situation or needs may change over
time, the screener will be re-
administered to intervention arm
participants at a minimum every 3–4
months during a clinic visit or other
arranged face-to-face meetings outside
of the clinic. In addition, the study
coordinator will obtain contact/locator
information for all participants enrolled
in the intervention arm. Contact
information will be updated as
necessary by the intervention staff.
The response burden for the six
participating sites and patients enrolled
in the study is estimated as:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Phase 1
Primary Care Provider Survey ........................................................
Clinic Staff Survey ..........................................................................
Patient Exit Survey .........................................................................
.........................................................................................................
Electronic data abstraction .............................................................
150
270
1,800
4
4
1
600
1,080
1,800
6
4
24
Phase 1 Burden .......................................................................
2,226
....................
3,504
......................
1,300
Phase 2
Primary Care Provider Survey ........................................................
Clinic Staff Survey ..........................................................................
Patient Exit Survey .........................................................................
Patient Eligibility Screener * ............................................................
Patient Baseline Survey * ...............................................................
Retention Risk Screener .................................................................
Retention Specialist/Patient Navigator Encounter ..........................
Contact/locator information .............................................................
Electronic data abstraction .............................................................
150
270
1,800
3,000
1,800
1,200
12
1,200
6
2
2
1
1
1
4
300
4
4
300
540
1,800
3,000
1,800
4,800
3,600
4,800
24
0.167
0.167
0.033
0.083
0.50
0.25
0.017
0.083
40.0
50
90
60
249
900
1,200
61
398
960
Phase 2 ...................................................................................
8,238
....................
20,664
......................
3,968
Total Burden .....................................................................
11,664
....................
24,168
......................
5,268
Type of form by phase
Total
responses
Average burden per
response
(in hours)
0.167
0.167
0.033
40.0
Total burden
(in hours)
100
180
60
960
* Only administered one time during the entire project period.
mstockstill on DSKH9S0YB1PROD with NOTICES
Written comments and
recommendations concerning this
proposed information collection should
be sent within 30 days of this notice to:
Office of Management and Budget,
Office of Regulatory Affairs, New
Executive Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for HRSA.
Dated: July 27, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–18524 Filed 8–3–09; 8:45 am]
BILLING CODE 4165–15–P
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0277]
Authorization of Emergency Use of
Certain In Vitro Diagnostic Devices;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
issuance of two Emergency Use
Authorizations (EUAs) (the
Authorizations), one of which was
amended, for certain in vitro diagnostic
devices. FDA is issuing the
Authorizations under the Federal Food,
Drug, and Cosmetic Act (the act), as
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
requested by the Centers for Disease
Control and Prevention (CDC). The
Authorizations contain, among other
things, conditions on the emergency use
of the authorized in vitro diagnostics.
The Authorizations follow the
determination by the Acting Secretary of
the Department of Health and Human
Services, Charles E. Johnson (the Acting
Secretary), that a public health
emergency exists involving Swine
Influenza A (now known as 2009 H1N1
Influenza A or 2009 H1N1 flu) that
affects, or has the significant potential to
affect, national security. On the basis of
such determination, the Acting
Secretary declared an emergency
justifying the authorization of the
emergency use of certain in vitro
diagnostics, accompanied by emergency
use information subject to the terms of
any authorization issued under the act.
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38635-38636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18524]
-----------------------------------------------------------------------
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:
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 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 pre-intervention 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
quarterly during Phase 1 and semi-annually 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.
[[Page 38636]]
Participants randomly assigned into the intervention arms will
receive comprehensive or brief interventional services from two trained
interventionists. The interventions will be delivered in face-to-face
encounters as well as over the telephone and the first dose of the
intervention will be delivered on the day the participant is enrolled
into study. During the first face-to-face encounter, an interventionist
will administer a retention risk screener. This screener is a clinical
tool that will help identify attitudes, barriers, and unmet needs that
might prevent a patient from staying in care. The screener contains
three sections: (1) Attitudes and beliefs about HIV care and treatment,
(2) barriers to consistent clinic attendance (e.g., transportation,
child care, housing instability, scheduling problems, and lack of
social support), and (3) recent drug/alcohol use and mental health. The
information obtained from the risk screener will be used to tailor the
interventions to each individual patient's needs. Because a patient's
situation or needs may change over time, the screener will be re-
administered to intervention arm participants at a minimum every 3-4
months during a clinic visit or other arranged face-to-face meetings
outside of the clinic. In addition, the study coordinator will obtain
contact/locator information for all participants enrolled in the
intervention arm. Contact information will be updated as necessary by
the intervention staff.
The response burden for the six participating sites and patients
enrolled in the study is estimated as:
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses Total burden per Total
Type of form by phase respondents per responses response (in burden (in
respondent hours) hours)
----------------------------------------------------------------------------------------------------------------
Phase 1
Primary Care Provider Survey.............. 150 4 600 0.167 100
Clinic Staff Survey....................... 270 4 1,080 0.167 180
Patient Exit Survey....................... 1,800 1 1,800 0.033 60
6 4 24 40.0 960
Electronic data abstraction...............
-----------------------------------------------------------------
Phase 1 Burden........................ 2,226 ........... 3,504 ............ 1,300
----------------------------------------------------------------------------------------------------------------
Phase 2
Primary Care Provider Survey.............. 150 2 300 0.167 50
Clinic Staff Survey....................... 270 2 540 0.167 90
Patient Exit Survey....................... 1,800 1 1,800 0.033 60
Patient Eligibility Screener *............ 3,000 1 3,000 0.083 249
Patient Baseline Survey *................. 1,800 1 1,800 0.50 900
Retention Risk Screener................... 1,200 4 4,800 0.25 1,200
Retention Specialist/Patient Navigator 12 300 3,600 0.017 61
Encounter................................
Contact/locator information............... 1,200 4 4,800 0.083 398
Electronic data abstraction............... 6 4 24 40.0 960
-----------------------------------------------------------------
Phase 2............................... 8,238 ........... 20,664 ............ 3,968
-----------------------------------------------------------------
Total Burden...................... 11,664 ........... 24,168 ............ 5,268
----------------------------------------------------------------------------------------------------------------
* Only administered one time during the entire project period.
Written comments and recommendations concerning this proposed
information collection should be sent within 30 days of this notice to:
Office of Management and Budget, Office of Regulatory Affairs, New
Executive Office Building, Room 10235, Washington, DC 20503, Attention:
Desk Officer for HRSA.
Dated: July 27, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-18524 Filed 8-3-09; 8:45 am]
BILLING CODE 4165-15-P
