Agency Information Collection Activities: Proposed Collection; Comment Request, 18386-18388 [E9-9193]
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18386
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
The sponsors of covered studies will
be required to maintain complete
records of compensation agreements
with any compensation paid to
nonemployee clinical investigators,
including information showing any
financial interests held by the clinical
investigator, for a time period of 2 years
after the date of approval of the
applications. This time is consistent
with the current recordkeeping
requirements for other information
related to marketing applications for
human drugs, biologics, and medical
devices. Currently, sponsors of covered
studies must maintain many records
with regard to clinical investigators,
including protocol agreements and
investigator resumes or curriculum
vitae. FDA estimates than an average of
15 minutes will be required for each
recordkeeper to add this record to
clinical investigators’ file.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
54.6
Annual Frequency per
Recordkeeping
1,000
Total Annual
Records
1
Hours per Record
1,000
.25
Total
1There
250
250
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–9148 Filed 4–21–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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.
operating a Fetal Alcohol Spectrum
Disorder (FASD) Center of Excellence
which addresses FASD mainly by
providing trainings and technical
assistance; and developing and
supporting systems of care that respond
to FASD using effective evidence based
practices and interventions.
Currently the integration of evidencebased practices into service delivery
organizations is being accomplished
through subcontracts. One such
intervention which integrates
prevention strategies into service
delivery organizations is the ParentChild Assistance Program (PCAP)
targeting pregnant or postpartum
women. The PCAP programs uses the
following 12 data collection tools.
Proposed Project: Parent-Child
Assistance Program (P–CAP) in the
Fetal Alcohol Spectrum Disorder
(FASD) Center of Excellence—New
Description of Instruments/Activity for
Parent-Child Assistance Program (P–
CAP)
Since 2001, SAMHSA’s Center for
Substance Abuse Prevention has been
Instrument/activity
Description
At Baseline/Enrollment:
CRSQ ..........................................................
ASI—Part A .................................................
ASI—Part B & Twin .....................................
Demographic Data .......................................
dwashington3 on PROD1PC60 with NOTICES
Total Hours
Process Monitoring:
Weekly Advocate Time Summary ...............
Monthly Updates ..........................................
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The Community Referral Screening Questionnaire (CRSQ) is a screening form administered to
individuals referred to PCAP. The purpose of the form is to determine eligibility for enrollment in PCAP.
The Alcohol Severity Index (ASI) Part A is an intake interview administered at client enrollment. The ASI Part A includes questions about past 30 day alcohol use, lifetime use, age at
first use, month and year of last use, range of use (T–ACE), and use during pregnancy,
thereby providing a thorough assessment of alcohol consumption.
The Alcohol Severity Index (ASI) Part B is an intake interview administered as soon as possible after the target child birth. The ASI Part B includes questions about the target child at
birth and alcohol use during the pregnancy. If the target birth is of twins then the Twins Addendum form is administered.
The Demographic Questionnaire is administered after client enrollment. The questionnaire includes race, educational attainment, martial status, and an alcohol assessment.
The PCAP Weekly Advocate Time Summary Sheet is administered on a weekly basis. The
form tracks time spent on the phone, in person, or providing transportation to each client.
The Monthly Update form is administered on a monthly basis. The form records any changes
in drug and alcohol use, pregnancy, child custody, and sources of income.
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22APN1
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Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
Instrument/activity
Description
Biannual Documentation of Progress (every
6 months).
At Exit:
Exit ASI ........................................................
Client Exit Close Out form ...........................
Ad hoc:
Advocate Accounting of Tracing Activity on
Missing Post-Exit Client.
Lost Post-Exit Client Form ..........................
Two PCAP subcontracts were
awarded in February 2008. PCAP uses
an intensive paraprofessional home
visitation model to reduce risk
behaviors in pregnant women with
substance abuse problems. The primary
goal of PCAP is to prevent future births
of alcohol and drug exposed children to
women who are at risk. The program
uses a holistic case management
approach, which is a complement to
traditional substance abuse treatment. In
addition to addressing alcohol and drug
use, the program also aims at reducing
other risk behaviors and addressing the
The Biannual Documentation of Progress is administered every six months. The form documents changes in alcohol/drug treatment, abstinence from alcohol/drugs, birth control and
pregnancy, connection to other services, and family stability and client activity.
The Exit ASI Follow-Up is administered at the end of the program, at 36 months. The Exit ASI
uses a format that is identical to the Addiction Severity Index administered at intake, providing pre- and post-test data for the intervention.
The Client Exit Close-Out Form documents the total number of months the client spent in
PCAP, number of different advocates who worked with the client, and whether the client
ever moved out of the area while enrolled in PCAP.
The Advocate Accounting of Tracing Activity on Missing Post-Exit Client is used to track activity to locate a missing client. When a client is missing, the form is to be completed each
month, instead of the Monthly Update form, until the missing post-exit client is brought in for
an Exit Interview.
The Lost Post-Exit Client Form is used when the client is at least six months past her three
year exit date in the program and has not completed the ASI exit interview. The form documents the reason the client has not completed the ASI exit interview.
health and social well being of mothers
and their children.
At the initial client visit, the women
receive a comprehensive assessment
which includes an assessment for
alcohol consumption, contraception
use, and use of community services. Atrisk women receive case management
and every 4 months women are reevaluated to determine their clinical
goals. Counselors complete
‘‘Documentation of Client Progress’’
form every 6 months and a final
‘‘Documentation of Client Progress’’ at
36 months. In addition, the counselors
complete a weekly advocate time sheet,
summarizing their activities within the
program. All forms are completed
online using the Web-portal. All
participating subcontractors will
maintain identifiable information on
clients for service delivery purposes but
no identifiable information will be
transmitted to SAMHSA.
The data collection is designed to
evaluate the implementation of PCAP by
measuring whether abstinence from
alcohol is achieved and risk for alcoholexposed births is eliminated.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
2 sites
Instrument/activity
At Baseline/Enrollment:
CRSQ .......................................................................................
ASI—Part A ..............................................................................
ASI—Part B & Twin ..................................................................
Demographic Data ....................................................................
Process Monitoring:
Weekly Advocate Time Summary ............................................
Monthly Updates .......................................................................
Biannual Documentation of Progress (every 6 months) ..........
At Exit:
Exit ASI .....................................................................................
Client Exit Close Out form ........................................................
Ad hoc:
Advocate Accounting of Tracing Activity on Missing Post-Exit
Client .....................................................................................
Lost Post-Exit Client Form ........................................................
dwashington3 on PROD1PC60 with NOTICES
Total ...................................................................................
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Number of
responses per
respondent
Average burden
per response
Total burden
hours per
collection
190
190
190
190
1
1
1
1
0.08
2.75
0.25
0.08
15
523
47.5
15
190
190
161
52
12
2
0.50
0.50
0.33
4,940
1,140
106
190
161
1
1
2.25
0.25
428
40
29
29
1
1
0.25
0.25
7
7
1,710
74
............................
7,269
Sfmt 4703
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22APN1
18388
Federal Register / Vol. 74, No. 76 / Wednesday, April 22, 2009 / Notices
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
Dated: April 13, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–9193 Filed 4–21–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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.
Proposed Project: Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (OMB No. 0930–
0158)—Extension
SAMHSA’s Mandatory Guidelines for
Federal Workplace Drug Testing
Programs will request OMB approval for
the Federal Drug Testing Custody and
Control Form for Federal agency and
federally regulated drug testing
programs which must comply with the
HHS Mandatory Guidelines for Federal
Workplace Drug Testing Programs (69
FR 19644) dated April 13, 2004, and for
the information provided by laboratories
for the National Laboratory Certification
Program (NLCP).
The Federal Drug Testing Custody
and Control Form is used by all Federal
agencies and employers regulated by the
Department of Transportation to
document the collection and chain of
custody of urine specimens at the
collection site, for laboratories to report
results, and for Medical Review Officers
to make a determination. The Federal
Drug Testing Custody and Control Form
approved by OMB three years ago is
being resubmitted for OMB approval
without any revision.
Prior to an inspection, a laboratory is
required to submit specific information
regarding its laboratory procedures.
Collecting this information prior to an
inspection allows the inspectors to
thoroughly review and understand the
laboratory’s testing procedures before
arriving at the laboratory.
The NLCP application form has not
been revised compared to the previous
form.
The annual total burden estimates for
the Federal Drug Testing Custody and
Control Form, the NLCP application, the
NLCP inspection checklist, and NLCP
recordkeeping requirements are shown
in the following table.
Burden/
response
(hrs.)
Form/respondent
Number of
responses
Total annual
burden
(hrs.)
Custody and Control Form:
Donor ....................................................................................................................................
Collector ................................................................................................................................
Laboratory .............................................................................................................................
Medical Review Officer .........................................................................................................
Laboratory Application .................................................................................................................
Laboratory Inspection Checklist ..................................................................................................
Laboratory Recordkeeping ..........................................................................................................
.08
.07
.05
.05
3.00
3.00
250.00
7,096,000
7,096,000
7,096,000
7,096,000
3
100
50
567,680
496,720
354,800
354,800
9
300
12,500
Total ......................................................................................................................................
........................
........................
1,786,809
dwashington3 on PROD1PC60 with NOTICES
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857 and e-mail her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 13, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–9187 Filed 4–21–09; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
BILLING CODE 4162–20–P
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15:31 Apr 21, 2009
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National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
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property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel, Nutrition and
Aging of Brain.
Date: June 9, 2009.
Time: 11 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
National Institutes of Health, Gateway
Building, Room 2C/212, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
PhD, Scientific Review Officer, National
E:\FR\FM\22APN1.SGM
22APN1
]]>Agencies
[Federal Register Volume 74, Number 76 (Wednesday, April 22, 2009)]
[Notices]
[Pages 18386-18388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are 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.
Proposed Project: Parent-Child Assistance Program (P-CAP) in the Fetal
Alcohol Spectrum Disorder (FASD) Center of Excellence--New
Since 2001, SAMHSA's Center for Substance Abuse Prevention has been
operating a Fetal Alcohol Spectrum Disorder (FASD) Center of Excellence
which addresses FASD mainly by providing trainings and technical
assistance; and developing and supporting systems of care that respond
to FASD using effective evidence based practices and interventions.
Currently the integration of evidence-based practices into service
delivery organizations is being accomplished through subcontracts. One
such intervention which integrates prevention strategies into service
delivery organizations is the Parent-Child Assistance Program (PCAP)
targeting pregnant or postpartum women. The PCAP programs uses the
following 12 data collection tools.
Description of Instruments/Activity for Parent-Child Assistance Program
(P-CAP)
----------------------------------------------------------------------------------------------------------------
Instrument/activity Description
----------------------------------------------------------------------------------------------------------------
At Baseline/Enrollment:
CRSQ.................................... The Community Referral Screening Questionnaire (CRSQ) is a
screening form administered to individuals referred to PCAP. The
purpose of the form is to determine eligibility for enrollment in
PCAP.
ASI--Part A............................. The Alcohol Severity Index (ASI) Part A is an intake interview
administered at client enrollment. The ASI Part A includes
questions about past 30 day alcohol use, lifetime use, age at
first use, month and year of last use, range of use (T-ACE), and
use during pregnancy, thereby providing a thorough assessment of
alcohol consumption.
ASI--Part B & Twin...................... The Alcohol Severity Index (ASI) Part B is an intake interview
administered as soon as possible after the target child birth.
The ASI Part B includes questions about the target child at birth
and alcohol use during the pregnancy. If the target birth is of
twins then the Twins Addendum form is administered.
Demographic Data........................ The Demographic Questionnaire is administered after client
enrollment. The questionnaire includes race, educational
attainment, martial status, and an alcohol assessment.
Process Monitoring:
Weekly Advocate Time Summary............ The PCAP Weekly Advocate Time Summary Sheet is administered on a
weekly basis. The form tracks time spent on the phone, in person,
or providing transportation to each client.
Monthly Updates......................... The Monthly Update form is administered on a monthly basis. The
form records any changes in drug and alcohol use, pregnancy,
child custody, and sources of income.
[[Page 18387]]
Biannual Documentation of Progress The Biannual Documentation of Progress is administered every six
(every 6 months). months. The form documents changes in alcohol/drug treatment,
abstinence from alcohol/drugs, birth control and pregnancy,
connection to other services, and family stability and client
activity.
At Exit:
Exit ASI................................ The Exit ASI Follow-Up is administered at the end of the program,
at 36 months. The Exit ASI uses a format that is identical to the
Addiction Severity Index administered at intake, providing pre-
and post-test data for the intervention.
Client Exit Close Out form.............. The Client Exit Close-Out Form documents the total number of
months the client spent in PCAP, number of different advocates
who worked with the client, and whether the client ever moved out
of the area while enrolled in PCAP.
Ad hoc:
Advocate Accounting of Tracing Activity The Advocate Accounting of Tracing Activity on Missing Post-Exit
on Missing Post-Exit Client. Client is used to track activity to locate a missing client. When
a client is missing, the form is to be completed each month,
instead of the Monthly Update form, until the missing post-exit
client is brought in for an Exit Interview.
Lost Post-Exit Client Form.............. The Lost Post-Exit Client Form is used when the client is at least
six months past her three year exit date in the program and has
not completed the ASI exit interview. The form documents the
reason the client has not completed the ASI exit interview.
----------------------------------------------------------------------------------------------------------------
Two PCAP subcontracts were awarded in February 2008. PCAP uses an
intensive paraprofessional home visitation model to reduce risk
behaviors in pregnant women with substance abuse problems. The primary
goal of PCAP is to prevent future births of alcohol and drug exposed
children to women who are at risk. The program uses a holistic case
management approach, which is a complement to traditional substance
abuse treatment. In addition to addressing alcohol and drug use, the
program also aims at reducing other risk behaviors and addressing the
health and social well being of mothers and their children.
At the initial client visit, the women receive a comprehensive
assessment which includes an assessment for alcohol consumption,
contraception use, and use of community services. At-risk women receive
case management and every 4 months women are re-evaluated to determine
their clinical goals. Counselors complete ``Documentation of Client
Progress'' form every 6 months and a final ``Documentation of Client
Progress'' at 36 months. In addition, the counselors complete a weekly
advocate time sheet, summarizing their activities within the program.
All forms are completed online using the Web-portal. All participating
subcontractors will maintain identifiable information on clients for
service delivery purposes but no identifiable information will be
transmitted to SAMHSA.
The data collection is designed to evaluate the implementation of
PCAP by measuring whether abstinence from alcohol is achieved and risk
for alcohol-exposed births is eliminated.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Number of Total burden
Instrument/activity respondents 2 responses per Average burden hours per
sites respondent per response collection
----------------------------------------------------------------------------------------------------------------
At Baseline/Enrollment:
CRSQ................................ 190 1 0.08 15
ASI--Part A......................... 190 1 2.75 523
ASI--Part B & Twin.................. 190 1 0.25 47.5
Demographic Data.................... 190 1 0.08 15
Process Monitoring:
Weekly Advocate Time Summary........ 190 52 0.50 4,940
Monthly Updates..................... 190 12 0.50 1,140
Biannual Documentation of Progress 161 2 0.33 106
(every 6 months)...................
At Exit:
Exit ASI............................ 190 1 2.25 428
Client Exit Close Out form.......... 161 1 0.25 40
Ad hoc:
Advocate Accounting of Tracing 29 1 0.25 7
Activity on Missing Post-Exit
Client.............................
Lost Post-Exit Client Form.......... 29 1 0.25 7
-----------------------------------------------------------------------
Total........................... 1,710 74 ................ 7,269
----------------------------------------------------------------------------------------------------------------
[[Page 18388]]
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail her
a copy at summer.king@samhsa.hhs.gov. Written comments should be
received within 60 days of this notice.
Dated: April 13, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-9193 Filed 4-21-09; 8:45 am]
BILLING CODE 4162-20-P
