Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57499-57503 [E9-26803]
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Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: October 30, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–26829 Filed 11–5–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Native Employment Works
(NEW) Program Plan Guidance and
Report Requirements.
OMB No.: 0970–0174.
Description: The Native Employment
Works (NEW) program plan is the
application for NEW program funding.
As approved by the Department of
Health and Human Services (HHS), it
documents how the grantee will carry
out its NEW program. The NEW
program plan guidance provides
instructions for preparing a NEW
program plan and explains the process
for plan submission every third year.
The NEW program report provides
information on the activities and
accomplishments of grantees’ NEW
programs. The NEW program report and
instructions specify the program data
that NEW grantees report annually.
Respondents: Federally recognized
Indian Tribes and Tribal organizations
that are NEW program grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
NEW program plan guidance ..........................................................................................
NEW program report .......................................................................................................
26
48
1
1
Estimated Total Annual Burden
Hours: 1,474.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7245,
Attn: Desk Officer for the
Administration for Children and
Families.
during 5 interviews (baseline and 4
follow-ups) over a 12-month period after
enrollment or discharge from treatment.
Approximately 200 collateral
respondents (i.e., a parent/guardian/
concerned other) will be asked to
complete 7 data collection forms (some
repeated) during 5 interviews (baseline
and 4 follow-ups) over a 12-month
period after their adolescent’s
enrollment or discharge from treatment.
Approximately 15 to 20 project staff
respondents, including Project
Coordinators, Telephone Support
Volunteers, a Social Network Site
Moderator, Family Program Clinicians,
and a Support Services Supervisor, will
be asked to complete between 2 and 5
data collection forms at varying
intervals during the delivery of recovery
support services. Across all
respondents, a total of 28 data collection
forms will be used. Depending on the
time interval and task, information
collections will take anywhere from
about 5 minutes to 2 hours to complete.
A description of each data collection
form follows:
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Instrument
Dated: November 2, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–26731 Filed 11–5–09; 8:45 am]
BILLING CODE 4184–01–P
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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: Recovery Services for
Adolescents and Families—New
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Substance Abuse
Treatment will conduct a data collection
on the helpfulness of recovery support
services for whether young people and
their families after leaving substance
abuse treatment. Specifically, the
Recovery Services for Adolescents and
Families (RSAF) project is evaluating a
pilot test of the following recovery
support services for whether young
people and their families find the
following recovery support services
helpful: (1) Telephone/text message
support; (2) a recovery-oriented social
networking site; and (3) a family
program. Approximately 200 adolescent
respondents will be asked to complete
4 data collection forms (some repeated)
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Average
burden
hours per
response
29
15
Total
burden
hours
754
720
Adolescent Participant
• Global Appraisal of Individual
Needs—Initial (GAIN–I 5.6.0 Full). The
GAIN is an evidence-based assessment
used with both adolescents and adults
and in outpatient, intensive outpatient,
partial hospitalization, methadone,
short-term residential, long-term
residential, therapeutic community, and
correctional programs. There are over
1000 questions in this initial version
that are in multiple formats, including
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Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
multiple choice, yes/no, and openended. Eight content areas are covered:
Background, Substance Use, Physical
Health, Risk Behaviors and Disease
Prevention, Mental and Emotional
Health, Environment and Living
Situation, Legal, and Vocational. Each
section contains questions on the
recency of problems, breadth of
symptoms, and recent prevalence as
well as lifetime service utilization,
recency of utilization, and frequency of
recent utilization. GPRA data are
gathered as part of this instrument in
support of performance measurement
for SAMHSA programs. It is
administered at intake into treatment by
clinical staff and used as baseline data
for the project.
• Global Appraisal of Individual
Needs—Monitoring 90 Days (GAIN–M90
5.6.0 Full). The GAIN is an evidencebased assessment used with both
adolescents and adults and in
outpatient, intensive outpatient, partial
hospitalization, methadone, short-term
residential, long-term residential,
therapeutic community, and
correctional programs. There are over
500 questions in this follow-up version
that are in multiple formats, including
multiple choice, yes/no, and openended. Eight content areas are covered:
Background, Substance Use, Physical
Health, Risk Behaviors and Disease
Prevention, Mental and Emotional
Health, Environment and Living
Situation, Legal, and Vocational. Each
section contains questions on the
recency of problems, breadth of
symptoms, and recent prevalence as
well as lifetime service utilization,
recency of utilization, and frequency of
recent utilization. GPRA data are
gathered as part of this instrument in
support of performance measurement
for SAMHSA programs. It is
administered by project staff at each of
the follow-up timepoints.
• Supplemental Assessment Form
(SAF 0309). The SAF contains 72
questions that are a combination of
multiple choice, yes/no, and openended formats. Content areas include:
race, happiness with parent or caregiver
in several life areas, participation in
prosocial activities, receipt of and
satisfaction with telephone support
services, and usage of and satisfaction
with the project’s social networking site.
It is administered by project staff at each
of the follow-up timepoints.
Collateral Participant (parent/guardian)
• Global Appraisal of Individual
Needs—Collateral Monitoring—Initial
(GCI). The GCI contains over 200 items
in this initial version that are in
multiple formats, including multiple
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choice, yes/no, and open-ended. The
following content areas are covered:
relationship to the adolescent
respondent, background, and the
adolescent’s background and substance
use, environment and living situation,
and vocational information. There are
questions on the recency of problems,
breadth of symptoms, and recent
prevalence as well as lifetime service
utilization, recency of utilization, and
frequency of recent utilization. It is
administered at baseline by project staff.
• Global Appraisal of Individual
Needs—Collateral Monitoring—
Monitoring (GCM 5.3.3). The GCM
contains over 200 items in this followup version that are in multiple formats,
including multiple choice, yes/no, and
open-ended. The following content
areas are covered: relationship to the
adolescent respondent, background, and
the adolescent’s background and
substance use, environment and living
situation, and vocational information.
There are questions on the recency of
problems, breadth of symptoms, and
recent prevalence as well as lifetime
service utilization, recency of
utilization, and frequency of recent
utilization. It is administered at each of
the follow-up timepoints by project staff
• Supplemental Assessment Form—
Collateral (SAF—Collateral). The SAF
contains 72 questions that are a
combination of multiple choice, yes/no,
and open-ended formats. Content areas
include: knowledge about the
adolescent’s participation in prosocial
activities, receipt of and satisfaction
with telephone support services, and
usage of and satisfaction with the
project’s social networking site. It is
administered at each of the follow-up
timepoints by project staff.
• Self-Evaluation Questionnaire
(SEQ). The SEQ contains 40 multiple
choice items that ask the collateral
about feelings and symptoms of anxiety.
It is administered at each of the followup timepoints by project staff.
• Family Environment Scale (FES).
The FES contains 18 yes/no items that
measure family cohesion and conflict. It
is administered at each of the follow-up
timepoints by project staff.
• Relationship Happiness Scale
(Caregiver Version). The Relationship
Happiness Scale contains 8 items that
ask the collateral about happiness with
his/her relationship with the adolescent
respondent in various life areas. It is
administered at each of the follow-up
timepoints by project staff.
Project Coordinator
• Eligibility Checklist. The Eligibility
Checklist contains 12 yes/no items that
are used to determine whether or not an
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adolescent meets inclusion/exclusion
criteria for the project and is eligible to
be approached for informed consent. It
is completed prior to informed consent
by project staff.
• Telephone Support Volunteer
Notification Form. This form contains a
participant’s name and contact
information. It is completed by project
staff and given to volunteers to notify
them when someone is assigned to
receive telephone support.
• Family Program Notification Form.
This form contains a participant’s name.
It is completed by project staff and given
to clinicians to notify them when
someone is assigned to the family
support group.
• Follow-Up Locator Form—
Participant (FLF–P). The FLF–P
contains over 50 items that are a
combination of yes/no, multiple choice,
and open-ended formats. At the time of
informed consent, data are gathered by
project staff about an adolescent’s
contact information, personal contacts,
criminal justice contacts, school/job
contacts, hang-out information, Internet
contacts, and identifying information in
order to locate and interview that
adolescent over multiple follow-up
intervals.
• Follow-Up Locator Form—
Collateral (FLF–C). The FLF–C contains
over 50 items that are a combination of
yes/no, multiple choice, and openended formats. Data are gathered about
a collateral’s contact information,
personal contacts, and job contacts in
order to locate and interview that
collateral over multiple follow-up
intervals. It is administered at the time
of informed consent by project staff.
• Follow-Up Contact Log. The
Follow-Up Contact Log is open-ended
and provides space for all data collected
during attempted and completed followup contacts, over the phone and inperson, to be recorded. It is completed
throughout the follow-up timeperiod.
• Volunteer/Staff Survey. The
Volunteer/Staff Survey contains 10
items in fill-in-the-blank, yes/no, and
multiple choice formats. Items ask about
background, demographic information,
and role in the project. It is completed
once by all volunteers and staff at the
start of the project.
Telephone Support Volunteer
• Telephone Support Case Review
Form. The Telephone Support Case
Review Form contains multiple rows
that allow a volunteer to record 5 pieces
of data about adolescents that they make
phone calls to: initials, treatment
discharge status/date, weeks since
treatment discharge, date of last
telephone session, and number of
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completed telephone sessions since
discharge. This allows the volunteer and
supervisor to monitor the progress of
active cases. The form is completed by
the volunteers every week.
• Telephone Support Call Log. The
Telephone Support Call Log is openended and provides space for all data
collected during attempted and
completed support contacts to be
recorded. The form is completed by the
volunteer throughout the period of
telephone support.
• Adolescent Telephone Support
Documentation Form. The Adolescent
Telephone Support Documentation
Form contains 22 items that are asked
of an adolescent during a telephone
support contact by a volunteer. The
form is used to record yes/no and openended responses to questions asking
about substance use and recoveryrelated activities. The volunteers
complete the form every time there is a
telephone support session with an
adolescent.
• Telephone Support Discharge Form.
The Telephone Support Discharge Form
contains 10 fields to record the
following information at the end of an
adolescent’s participation in telephone
support: adolescent name, today’s date,
volunteer name, notification date,
telephone support intake date,
telephone support discharge date,
reason for discharge, number of
completed sessions, referral for more
intervention, and successful contact for
more intervention. This form is
completed by volunteers when
telephone support ends for each
adolescent.
• Volunteer/Staff Survey (Telephone
Support Volunteer)—See Volunteer/
Staff Survey (Project Coordinator)
above.
Social Network Site Moderator
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• Social Networking Moderator Log.
The Social Networking Moderator Log
contains 11 fields for the moderator to
record usage data for the project’s social
networking site. The moderator tracks
number of visits to the site, number of
unique visitors, messages posted, chat
room attendance, and problems with
users. This form is completed weekly by
project staff.
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• Volunteer/Staff Survey—See
Volunteer/Staff Survey (Project
Coordinator) above.
Family Program Clinician
• Family Program Progress Notes.
The Family Program Progress Notes
form is open-ended and provides space
for all data collected during attempted
and completed family program contacts
to be recorded. This form is completed
by the clinician throughout the time
family members are active in the family
support program.
• Family Program Attendance Log.
The Family Program Attendance Log is
used to record 6 pieces of information
about each attempted session: session
number, scheduled date, was the
session rescheduled (yes/no), was the
family member a no-show (yes/no), did
the family member attend the session
(yes/no), and comments. This form is
completed by the clinician throughout
the time family members are active in
the family support program.
• Family Program Case Review
Report. The Family Program Case
Review Report contains multiple rows
that allow a clinician to record
information that allows the clinician
and supervisor to monitor the progress
of active cases. Areas asked about
include: family program procedures
delivered, date of last session, and
weeks in family program. This form is
completed by the clinician weekly
throughout the time family members are
active in the family support program.
• Family Program Discharge Form.
The Family Program Discharge Form
contains 9 fields to record the following
information at the end of participation
in the family program: caregiver name,
today’s date, adolescent name,
notification date, clinician name, family
program intake date, family program
discharge date, reason for discharge, and
number of completed sessions. This
form is completed by the clinician each
time family members of a given
participant end involvement in the
family support program.
• Volunteer/Staff Survey—See
Volunteer/Staff Survey (Project
Coordinator) above.
Support Services Supervisor
• Adolescent Telephone Support
Quality Assurance Checklist. This
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checklist contains 43 items that ask the
supervisor to rate how well a telephone
support volunteer delivered required
service components to adolescents.
Volunteers are rated on a scale of 1
through 5 in the following areas:
substance use since last call (no use),
substance use since last call (use),
substance use since last call (still using),
substance use since last call (stopped
using), attendance at 12-step meetings,
recovery-related activities, activities
related to global health, follow-up since
last call, closing the call, overall, general
clinical skills, and overall difficulty of
session. This form is completed for each
reviewed recording of a telephone
session by a supervisor.
• Social Networking Quality
Assurance Checklist. This checklist
contains 17 items that ask the
supervisor to rate how well a social
networking site moderator delivered
required service components to
adolescents. The moderator is rated on
a scale of 1 through 5 in the following
areas: group discussions, administrative
tasks, overall, and general skills. This
form is completed for each review of the
social networking site by a supervisor.
• Family Program QA Checklist. This
checklist contains 72 items that ask the
supervisor to rate how well a family
program clinician delivered required
service components to family members.
The clinician is rated on a scale of 1
through 5 in the following areas: initial
meeting motivational strategies,
domestic violence precautions,
functional analysis of substance use,
positive communication skills, use of
positive reinforcement, time out from
positive reinforcement, allowing the
identified patient to experience the
natural consequences of substance use,
helping concerned significant others’
enrich their own lives, maintaining the
identified patient in recovery-oriented
systems of care, and general. This form
is completed for each reviewed
recording of a family session by a
supervisor.
• Volunteer/Staff Survey—See
Volunteer/Staff Survey (Project
Coordinator) above.
The following table is a list of the
hour burden of the information
collection by form and by respondent:
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Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
DETAILED INFORMATION ON FORMS GROUPED BY RESPONDENT
Responses
per
respondent
Number of
respondents
Instrument/form
Total
responses
Hours per
response
Total
annualized
hour
burden per
respondent*
Adolescent Participant
GAIN–I 5.6.0 Full .................................................................
GAIN–M90 5.6.0 Full ...........................................................
SAF ......................................................................................
200
200
200
1
4
5
200
800
1000
2
1
.25
2
4
1.25
Subtotal .........................................................................
200
........................
2000
........................
7.25
Collateral (parent/guardian/concerned other) Participant
200
200
200
200
200
200
1
4
5
5
5
5
200
800
1000
1000
1000
1000
.25
.25
.25
.16
.08
.08
.25
1
1.25
.8
.4
.4
Subtotal .........................................................................
200
........................
5000
........................
4.1
Project Coordinator:
Eligibility Checklist ........................................................
Locator—Participant .....................................................
Locator—Collateral .......................................................
Follow-Up Contact Log .................................................
Telephone Support Volunteer Notification Form ..........
Family Program Notification Form ................................
Volunteer/Staff Survey ..................................................
4
4
4
4
4
4
4
50
50
50
50
50
50
1
200
200
200
200
200
200
4
.25
.32
.25
.16
.16
.16
.25
12.5
16
12.5
8
8
8
.25
Subtotal ..................................................................
4
........................
1204
........................
65.25
Telephone Support Volunteer:
Telephone Support Case Review Form .......................
Telephone Support Call Log .........................................
Telephone Support Documentation Form ....................
Telephone Support Discharge Form ............................
Volunteer/Staff Survey ..................................................
8
8
8
8
8
450
25
450
25
1
3600
200
3600
200
8
.25
.16
.5
.16
.25
112.5
4
225
4
.25
Subtotal ..................................................................
8
........................
7608
........................
345.75
Social Network Site Moderator:
Social Networking Moderator Log ................................
Volunteer/Staff Survey ..................................................
1
1
52
1
52
1
.5
.25
26
.25
Subtotal ..................................................................
1
........................
53
........................
26.25
Family Program Clinician:
Family Program Progress Notes ..................................
Family Program Attendance Log ..................................
Family Program Case Review Form ............................
Family Program Discharge Form .................................
Volunteer/Staff Survey ..................................................
4
4
4
4
4
650
50
650
50
1
2600
200
2600
200
4
.16
.08
.25
.16
.25
104
4
162.5
8
.25
Subtotal ..................................................................
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Collateral–I ...........................................................................
Collateral–M .........................................................................
Collateral SAF ......................................................................
Self-Evaluation Questionnaire .............................................
Family Environment Scale (Cohesion and Conflict Scales)
Relationship Happiness Scale (Caregiver) ..........................
4
........................
5604
........................
278.75
Support Services Supervisor:
Telephone Support QA Checklist .................................
Social Networking QA Checklist ...................................
Family Program QA Checklist ......................................
Volunteer/Staff Survey ..................................................
1
1
1
1
12
12
12
1
12
12
12
1
1
.5
1
.25
12
6
12
.25
Subtotal ..................................................................
1
........................
37
........................
30.25
Total ................................................................
418
........................
21,506
........................
757.6
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57503
ANNUALIZED SUMMARY TABLE
Total
responses
Number of
respondents
Respondents
Total
annualized
hour burden per
respondent *
7.25
4.1
65.25
345.75
26.25
278.75
30.25
Adolescent .............................................................................................................................
Collateral ................................................................................................................................
Project Coordinator ................................................................................................................
Telephone Support Volunteer ................................................................................................
Social Network Site Moderator ..............................................................................................
Family Program Clinician .......................................................................................................
Support Services Supervisor .................................................................................................
200
200
4
8
1
4
1
2000
5000
1204
7608
53
5604
37
Total ................................................................................................................................
418
21,506
757.6
* Total Annualized Hour Burden per Respondent = Responses per Respondent × Hours per.
Written comments and
recommendations concerning the
proposed information collection should
be sent by December 7, 2009 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–
5806.
Dated: October 30, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–26803 Filed 11–5–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0319]
Guidance for Industry and Food and
Drug Administration Staff; In Vitro
Diagnostic 2009 H1N1 Tests for Use in
the 2009 H1N1 Emergency; Availability
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled ‘‘In
Vitro Diagnostic 2009 H1N1 Tests for
Use in the 2009 H1N1 Emergency.’’ FDA
is issuing this guidance to inform
industry and agency staff of its
recommendations for the type of
information and data FDA believes
needs to be included in an Emergency
Use Authorization Request (EUA) for in
vitro diagnostic (IVD) devices intended
for use in diagnosing 2009 H1N1
Influenza virus infections during the
emergency involving Swine Influenza
VerDate Nov<24>2008
18:23 Nov 05, 2009
Jkt 220001
A1. The Secretary of the Department of
Health and Human Services (HHS)
declared the emergency on April 26,
2009, in accordance with the Federal
Food, Drug, and Cosmetics Act (the
Act).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidelines
are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘In Vitro Diagnostic 2009 H1N1
Tests for Use in the 2009 H1N1
Emergency’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health WO/66, rm. 5552,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993, 301–796–5455.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document provides
recommendations on the types of
1 Swine Influenza A is now known as 2009 H1N1
Influenza (2009 H1N1).
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information and data that FDA believes
needs to be included in an Emergency
Use Authorization Request (EUA) for in
vitro diagnostic (IVD) devices intended
for use in diagnosing 2009 H1N1
Influenza virus infections during the
emergency involving Swine Influenza
A. While FDA encourages the
submission of premarket notifications
(510(k)s) for all 2009 H1N1 tests, the
agency is aware that during a declared
emergency, it may not be possible for
manufacturers of 2009 H1N1 tests to
submit a 510(k) prior to distributing or
offering a test. For example, during the
initial phase of the emergency, positive
clinical specimens may not be readily
available for use in device evaluations.
The identification of acute test capacity
need may limit the ability to test the
usual number of specimens needed for
a 510(k). Additionally, appropriate
validation specimens may not be
available in certain areas at the time the
test is needed. If manufacturers of 2009
H1N1 tests are unable to submit a
premarket notification and there is a
continued public health need for 2009
H1N1 tests during this declared
emergency, manufacturers should
submit an EUA request to FDA. Public
participation is not feasible or
appropriate since the agency must act
immediately to protect the public health
during the declared emergency
concerning 2009 H1N1 Influenza. This
guidance applies to 2009 H1N1 tests
during the time that the declaration of
emergency concerning 2009 H1N1
Influenza is in effect.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on in vitro diagnostic
2009 H1N1 tests for use in the 2009
H1N1 emergency. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
E:\FR\FM\06NON1.SGM
06NON1
]]>Agencies
[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57499-57503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26803]
-----------------------------------------------------------------------
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: Recovery Services for Adolescents and Families--New
The Substance Abuse and Mental Health Services Administration's
(SAMHSA) Center for Substance Abuse Treatment will conduct a data
collection on the helpfulness of recovery support services for whether
young people and their families after leaving substance abuse
treatment. Specifically, the Recovery Services for Adolescents and
Families (RSAF) project is evaluating a pilot test of the following
recovery support services for whether young people and their families
find the following recovery support services helpful: (1) Telephone/
text message support; (2) a recovery-oriented social networking site;
and (3) a family program. Approximately 200 adolescent respondents will
be asked to complete 4 data collection forms (some repeated) during 5
interviews (baseline and 4 follow-ups) over a 12-month period after
enrollment or discharge from treatment. Approximately 200 collateral
respondents (i.e., a parent/guardian/concerned other) will be asked to
complete 7 data collection forms (some repeated) during 5 interviews
(baseline and 4 follow-ups) over a 12-month period after their
adolescent's enrollment or discharge from treatment. Approximately 15
to 20 project staff respondents, including Project Coordinators,
Telephone Support Volunteers, a Social Network Site Moderator, Family
Program Clinicians, and a Support Services Supervisor, will be asked to
complete between 2 and 5 data collection forms at varying intervals
during the delivery of recovery support services. Across all
respondents, a total of 28 data collection forms will be used.
Depending on the time interval and task, information collections will
take anywhere from about 5 minutes to 2 hours to complete. A
description of each data collection form follows:
Adolescent Participant
Global Appraisal of Individual Needs--Initial (GAIN-I
5.6.0 Full). The GAIN is an evidence-based assessment used with both
adolescents and adults and in outpatient, intensive outpatient, partial
hospitalization, methadone, short-term residential, long-term
residential, therapeutic community, and correctional programs. There
are over 1000 questions in this initial version that are in multiple
formats, including
[[Page 57500]]
multiple choice, yes/no, and open-ended. Eight content areas are
covered: Background, Substance Use, Physical Health, Risk Behaviors and
Disease Prevention, Mental and Emotional Health, Environment and Living
Situation, Legal, and Vocational. Each section contains questions on
the recency of problems, breadth of symptoms, and recent prevalence as
well as lifetime service utilization, recency of utilization, and
frequency of recent utilization. GPRA data are gathered as part of this
instrument in support of performance measurement for SAMHSA programs.
It is administered at intake into treatment by clinical staff and used
as baseline data for the project.
Global Appraisal of Individual Needs--Monitoring 90 Days
(GAIN-M90 5.6.0 Full). The GAIN is an evidence-based assessment used
with both adolescents and adults and in outpatient, intensive
outpatient, partial hospitalization, methadone, short-term residential,
long-term residential, therapeutic community, and correctional
programs. There are over 500 questions in this follow-up version that
are in multiple formats, including multiple choice, yes/no, and open-
ended. Eight content areas are covered: Background, Substance Use,
Physical Health, Risk Behaviors and Disease Prevention, Mental and
Emotional Health, Environment and Living Situation, Legal, and
Vocational. Each section contains questions on the recency of problems,
breadth of symptoms, and recent prevalence as well as lifetime service
utilization, recency of utilization, and frequency of recent
utilization. GPRA data are gathered as part of this instrument in
support of performance measurement for SAMHSA programs. It is
administered by project staff at each of the follow-up timepoints.
Supplemental Assessment Form (SAF 0309). The SAF contains
72 questions that are a combination of multiple choice, yes/no, and
open-ended formats. Content areas include: race, happiness with parent
or caregiver in several life areas, participation in prosocial
activities, receipt of and satisfaction with telephone support
services, and usage of and satisfaction with the project's social
networking site. It is administered by project staff at each of the
follow-up timepoints.
Collateral Participant (parent/guardian)
Global Appraisal of Individual Needs--Collateral
Monitoring--Initial (GCI). The GCI contains over 200 items in this
initial version that are in multiple formats, including multiple
choice, yes/no, and open-ended. The following content areas are
covered: relationship to the adolescent respondent, background, and the
adolescent's background and substance use, environment and living
situation, and vocational information. There are questions on the
recency of problems, breadth of symptoms, and recent prevalence as well
as lifetime service utilization, recency of utilization, and frequency
of recent utilization. It is administered at baseline by project staff.
Global Appraisal of Individual Needs--Collateral
Monitoring--Monitoring (GCM 5.3.3). The GCM contains over 200 items in
this follow-up version that are in multiple formats, including multiple
choice, yes/no, and open-ended. The following content areas are
covered: relationship to the adolescent respondent, background, and the
adolescent's background and substance use, environment and living
situation, and vocational information. There are questions on the
recency of problems, breadth of symptoms, and recent prevalence as well
as lifetime service utilization, recency of utilization, and frequency
of recent utilization. It is administered at each of the follow-up
timepoints by project staff
Supplemental Assessment Form--Collateral (SAF--
Collateral). The SAF contains 72 questions that are a combination of
multiple choice, yes/no, and open-ended formats. Content areas include:
knowledge about the adolescent's participation in prosocial activities,
receipt of and satisfaction with telephone support services, and usage
of and satisfaction with the project's social networking site. It is
administered at each of the follow-up timepoints by project staff.
Self-Evaluation Questionnaire (SEQ). The SEQ contains 40
multiple choice items that ask the collateral about feelings and
symptoms of anxiety. It is administered at each of the follow-up
timepoints by project staff.
Family Environment Scale (FES). The FES contains 18 yes/no
items that measure family cohesion and conflict. It is administered at
each of the follow-up timepoints by project staff.
Relationship Happiness Scale (Caregiver Version). The
Relationship Happiness Scale contains 8 items that ask the collateral
about happiness with his/her relationship with the adolescent
respondent in various life areas. It is administered at each of the
follow-up timepoints by project staff.
Project Coordinator
Eligibility Checklist. The Eligibility Checklist contains
12 yes/no items that are used to determine whether or not an adolescent
meets inclusion/exclusion criteria for the project and is eligible to
be approached for informed consent. It is completed prior to informed
consent by project staff.
Telephone Support Volunteer Notification Form. This form
contains a participant's name and contact information. It is completed
by project staff and given to volunteers to notify them when someone is
assigned to receive telephone support.
Family Program Notification Form. This form contains a
participant's name. It is completed by project staff and given to
clinicians to notify them when someone is assigned to the family
support group.
Follow-Up Locator Form--Participant (FLF-P). The FLF-P
contains over 50 items that are a combination of yes/no, multiple
choice, and open-ended formats. At the time of informed consent, data
are gathered by project staff about an adolescent's contact
information, personal contacts, criminal justice contacts, school/job
contacts, hang-out information, Internet contacts, and identifying
information in order to locate and interview that adolescent over
multiple follow-up intervals.
Follow-Up Locator Form--Collateral (FLF-C). The FLF-C
contains over 50 items that are a combination of yes/no, multiple
choice, and open-ended formats. Data are gathered about a collateral's
contact information, personal contacts, and job contacts in order to
locate and interview that collateral over multiple follow-up intervals.
It is administered at the time of informed consent by project staff.
Follow-Up Contact Log. The Follow-Up Contact Log is open-
ended and provides space for all data collected during attempted and
completed follow-up contacts, over the phone and in-person, to be
recorded. It is completed throughout the follow-up timeperiod.
Volunteer/Staff Survey. The Volunteer/Staff Survey
contains 10 items in fill-in-the-blank, yes/no, and multiple choice
formats. Items ask about background, demographic information, and role
in the project. It is completed once by all volunteers and staff at the
start of the project.
Telephone Support Volunteer
Telephone Support Case Review Form. The Telephone Support
Case Review Form contains multiple rows that allow a volunteer to
record 5 pieces of data about adolescents that they make phone calls
to: initials, treatment discharge status/date, weeks since treatment
discharge, date of last telephone session, and number of
[[Page 57501]]
completed telephone sessions since discharge. This allows the volunteer
and supervisor to monitor the progress of active cases. The form is
completed by the volunteers every week.
Telephone Support Call Log. The Telephone Support Call Log
is open-ended and provides space for all data collected during
attempted and completed support contacts to be recorded. The form is
completed by the volunteer throughout the period of telephone support.
Adolescent Telephone Support Documentation Form. The
Adolescent Telephone Support Documentation Form contains 22 items that
are asked of an adolescent during a telephone support contact by a
volunteer. The form is used to record yes/no and open-ended responses
to questions asking about substance use and recovery-related
activities. The volunteers complete the form every time there is a
telephone support session with an adolescent.
Telephone Support Discharge Form. The Telephone Support
Discharge Form contains 10 fields to record the following information
at the end of an adolescent's participation in telephone support:
adolescent name, today's date, volunteer name, notification date,
telephone support intake date, telephone support discharge date, reason
for discharge, number of completed sessions, referral for more
intervention, and successful contact for more intervention. This form
is completed by volunteers when telephone support ends for each
adolescent.
Volunteer/Staff Survey (Telephone Support Volunteer)--See
Volunteer/Staff Survey (Project Coordinator) above.
Social Network Site Moderator
Social Networking Moderator Log. The Social Networking
Moderator Log contains 11 fields for the moderator to record usage data
for the project's social networking site. The moderator tracks number
of visits to the site, number of unique visitors, messages posted, chat
room attendance, and problems with users. This form is completed weekly
by project staff.
Volunteer/Staff Survey--See Volunteer/Staff Survey
(Project Coordinator) above.
Family Program Clinician
Family Program Progress Notes. The Family Program Progress
Notes form is open-ended and provides space for all data collected
during attempted and completed family program contacts to be recorded.
This form is completed by the clinician throughout the time family
members are active in the family support program.
Family Program Attendance Log. The Family Program
Attendance Log is used to record 6 pieces of information about each
attempted session: session number, scheduled date, was the session
rescheduled (yes/no), was the family member a no-show (yes/no), did the
family member attend the session (yes/no), and comments. This form is
completed by the clinician throughout the time family members are
active in the family support program.
Family Program Case Review Report. The Family Program Case
Review Report contains multiple rows that allow a clinician to record
information that allows the clinician and supervisor to monitor the
progress of active cases. Areas asked about include: family program
procedures delivered, date of last session, and weeks in family
program. This form is completed by the clinician weekly throughout the
time family members are active in the family support program.
Family Program Discharge Form. The Family Program
Discharge Form contains 9 fields to record the following information at
the end of participation in the family program: caregiver name, today's
date, adolescent name, notification date, clinician name, family
program intake date, family program discharge date, reason for
discharge, and number of completed sessions. This form is completed by
the clinician each time family members of a given participant end
involvement in the family support program.
Volunteer/Staff Survey--See Volunteer/Staff Survey
(Project Coordinator) above.
Support Services Supervisor
Adolescent Telephone Support Quality Assurance Checklist.
This checklist contains 43 items that ask the supervisor to rate how
well a telephone support volunteer delivered required service
components to adolescents. Volunteers are rated on a scale of 1 through
5 in the following areas: substance use since last call (no use),
substance use since last call (use), substance use since last call
(still using), substance use since last call (stopped using),
attendance at 12-step meetings, recovery-related activities, activities
related to global health, follow-up since last call, closing the call,
overall, general clinical skills, and overall difficulty of session.
This form is completed for each reviewed recording of a telephone
session by a supervisor.
Social Networking Quality Assurance Checklist. This
checklist contains 17 items that ask the supervisor to rate how well a
social networking site moderator delivered required service components
to adolescents. The moderator is rated on a scale of 1 through 5 in the
following areas: group discussions, administrative tasks, overall, and
general skills. This form is completed for each review of the social
networking site by a supervisor.
Family Program QA Checklist. This checklist contains 72
items that ask the supervisor to rate how well a family program
clinician delivered required service components to family members. The
clinician is rated on a scale of 1 through 5 in the following areas:
initial meeting motivational strategies, domestic violence precautions,
functional analysis of substance use, positive communication skills,
use of positive reinforcement, time out from positive reinforcement,
allowing the identified patient to experience the natural consequences
of substance use, helping concerned significant others' enrich their
own lives, maintaining the identified patient in recovery-oriented
systems of care, and general. This form is completed for each reviewed
recording of a family session by a supervisor.
Volunteer/Staff Survey--See Volunteer/Staff Survey
(Project Coordinator) above.
The following table is a list of the hour burden of the information
collection by form and by respondent:
[[Page 57502]]
Detailed Information on Forms Grouped by Respondent
----------------------------------------------------------------------------------------------------------------
Total
annualized
Instrument/form Number of Responses per Total Hours per hour burden
respondents respondent responses response per
respondent*
----------------------------------------------------------------------------------------------------------------
Adolescent Participant
----------------------------------------------------------------------------------------------------------------
GAIN-I 5.6.0 Full............... 200 1 200 2 2
GAIN-M90 5.6.0 Full............. 200 4 800 1 4
SAF............................. 200 5 1000 .25 1.25
-------------------------------------------------------------------------------
Subtotal.................... 200 .............. 2000 .............. 7.25
----------------------------------------------------------------------------------------------------------------
Collateral (parent/guardian/concerned other) Participant
----------------------------------------------------------------------------------------------------------------
Collateral-I.................... 200 1 200 .25 .25
Collateral-M.................... 200 4 800 .25 1
Collateral SAF.................. 200 5 1000 .25 1.25
Self-Evaluation Questionnaire... 200 5 1000 .16 .8
Family Environment Scale 200 5 1000 .08 .4
(Cohesion and Conflict Scales).
Relationship Happiness Scale 200 5 1000 .08 .4
(Caregiver)....................
-------------------------------------------------------------------------------
Subtotal.................... 200 .............. 5000 .............. 4.1
----------------------------------------------------------------------------------------------------------------
Project Coordinator:
Eligibility Checklist....... 4 50 200 .25 12.5
Locator--Participant........ 4 50 200 .32 16
Locator--Collateral......... 4 50 200 .25 12.5
Follow-Up Contact Log....... 4 50 200 .16 8
Telephone Support Volunteer 4 50 200 .16 8
Notification Form..........
Family Program Notification 4 50 200 .16 8
Form.......................
Volunteer/Staff Survey...... 4 1 4 .25 .25
-------------------------------------------------------------------------------
Subtotal................ 4 .............. 1204 .............. 65.25
----------------------------------------------------------------------------------------------------------------
Telephone Support Volunteer:
Telephone Support Case 8 450 3600 .25 112.5
Review Form................
Telephone Support Call Log.. 8 25 200 .16 4
Telephone Support 8 450 3600 .5 225
Documentation Form.........
Telephone Support Discharge 8 25 200 .16 4
Form.......................
Volunteer/Staff Survey...... 8 1 8 .25 .25
-------------------------------------------------------------------------------
Subtotal................ 8 .............. 7608 .............. 345.75
----------------------------------------------------------------------------------------------------------------
Social Network Site Moderator:
Social Networking Moderator 1 52 52 .5 26
Log........................
Volunteer/Staff Survey...... 1 1 1 .25 .25
-------------------------------------------------------------------------------
Subtotal................ 1 .............. 53 .............. 26.25
----------------------------------------------------------------------------------------------------------------
Family Program Clinician:
Family Program Progress 4 650 2600 .16 104
Notes......................
Family Program Attendance 4 50 200 .08 4
Log........................
Family Program Case Review 4 650 2600 .25 162.5
Form.......................
Family Program Discharge 4 50 200 .16 8
Form.......................
Volunteer/Staff Survey...... 4 1 4 .25 .25
-------------------------------------------------------------------------------
Subtotal................ 4 .............. 5604 .............. 278.75
----------------------------------------------------------------------------------------------------------------
Support Services Supervisor:
Telephone Support QA 1 12 12 1 12
Checklist..................
Social Networking QA 1 12 12 .5 6
Checklist..................
Family Program QA Checklist. 1 12 12 1 12
Volunteer/Staff Survey...... 1 1 1 .25 .25
-------------------------------------------------------------------------------
Subtotal................ 1 .............. 37 .............. 30.25
===============================================================================
Total............... 418 .............. 21,506 .............. 757.6
----------------------------------------------------------------------------------------------------------------
[[Page 57503]]
Annualized Summary Table
----------------------------------------------------------------------------------------------------------------
Total
annualized
Respondents Number of Total hour burden
respondents responses per
respondent *
----------------------------------------------------------------------------------------------------------------
Adolescent...................................................... 200 2000 7.25
Collateral...................................................... 200 5000 4.1
Project Coordinator............................................. 4 1204 65.25
Telephone Support Volunteer..................................... 8 7608 345.75
Social Network Site Moderator................................... 1 53 26.25
Family Program Clinician........................................ 4 5604 278.75
Support Services Supervisor..................................... 1 37 30.25
-----------------------------------------------
Total....................................................... 418 21,506 757.6
----------------------------------------------------------------------------------------------------------------
* Total Annualized Hour Burden per Respondent = Responses per Respondent x Hours per.
Written comments and recommendations concerning the proposed
information collection should be sent by December 7, 2009 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: 202-395-5806.
Dated: October 30, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-26803 Filed 11-5-09; 8:45 am]
BILLING CODE 4162-20-P
