Agency Information Collection Activities: Proposed Collection; Comment Request, 63775-63776 [E6-18266]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
document number 1558 to identify the
guidance you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved submissions, approved
applications, and manufacturers’
addresses), small manufacturer’s
assistance, information on video
conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
cprice-sewell on PROD1PC66 with NOTICES
IV. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to the review by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995 (the PRA) (44 U.S.C. 3501–3520).
The collections of information
addressed in the draft guidance
document have been approved by OMB
in accordance with the PRA under the
regulations governing premarket
notification submissions (21 CFR part
807, subpart E, OMB control number
0910–0120). The labeling provisions
addressed in the guidance have been
approved by OMB under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: October 19, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–18318 Filed 10–30–06; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:25 Oct 30, 2006
Jkt 211001
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 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: Cross-Site
Assessment of the Residential
Treatment for Pregnant and Postpartum
Women (PPW) and Their Children
Program—(OMB No. 0930–0269)—
Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center for Substance Abuse
Treatment (CSAT), is funding additional
Services Grants for Residential
Treatment for Pregnant and Postpartum
Women (PPW). The purpose of the PPW
is to expand the availability of
comprehensive, high quality residential
treatment services for pregnant and
postpartum women who suffer from
alcohol and other drug use problems,
and for their infants and children
impacted by the perinatal and
environmental effects of maternal
substance use and abuse.
Section 508 [290bb–1] of the Public
Health Service Act mandates the
evaluation and dissemination of
findings of residential treatment
programs for pregnant and postpartum
women. This cross-site accountability
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
63775
assessment will assess project activities
implemented for these services.
The grantees were brought to
consensus surrounding an evaluation
design and methods of data collection
with accompanying instruments, via the
work of the project officer and
consultant experts in the field. The data
collection instruments will be used for
program and treatment planning, local
evaluations, and for this cross-site
accountability evaluation. For mothers,
administration of data collection
instruments will occur at intake, 6
months post-intake, discharge, and 4
months post-discharge.1 The following
four different interview instruments will
be used for mothers:
1. Child Data Collection Tool, Part 1
(child’s personal background) and Part 2
(child’s medical background);
2. Ferrans and Powers Quality of Life
Index Generic Version—III;
3. BASIS–24 (pilot study used
BASIS–32)—behavioral health
assessment; and
4. Allen Barriers to Treatment
Instrument.
For all children under 18 years,
program staff will collect information
from observation, interview, and records
review. For infants and children, data
collection will occur at a time within 30
days of the mother’s intake or the
child’s birth, 3 months post-intake/
birth, 6 months post-intake/birth,
discharge, and 4 months postdischarge.1 Children’s data collection
tools include the following:
1. Child Well-Being Scales (staff
observation and records review for all
children);
2. Denver Developmental Screening
Inventory II (ages 0 to 6 years, 0 days);
3. Middle Childhood Developmental
Assessment Guide (ages 6 to 10);
4. Adolescent Childhood
Development Assessment Guide (ages
11 to 17); and
5. CRAFFT substance abuse screening
instrument (ages 11–17).
In addition, records review will be
conducted by program staff on all
program participants. First, at each data
collection period except for 4 months
post-discharge, staff will complete the
Women’s Medical Record Audit and the
Child’s Medical Record Audit (or the
Newborn’s Medical Record Audit at
delivery.) Second, staff will complete
the Women’s Discharge Tool and the
Children’s Discharge Tool at discharge.
1 The 4 month post-discharge administration
replaces the 12-month post-admission
administration approved by OMB for the pilot
study. This modification was made because it is
believed that post-discharge followup information
will be more informative and will have more cases
than 12 months post-admission.
E:\FR\FM\31OCN1.SGM
31OCN1
63776
Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
All data will be collected using a
combination of observation, records
review, self-administered paper-andpencil questionnaires, and personal
interviews. CSAT will use this data for
this evaluation to inform public policy,
research, and programming as they
relate to the provision of women’s
services. Data produced by this study
will provide direction to the type of
technical assistance that will be
required by service providers of
women’s programming. In addition, the
data will be used by individual grantees
to support progress report efforts.
The following table shows the
estimated annual response burden for
this collection.
ESTIMATES OF BURDEN HOURS
Number of
respondents
Form name/type of administration
Responses per respondent
Total responses
Hours per
response
Total hour
burden
Women Interviews
Child Data Collection Tool (Personal Interview) .................
Allen Barriers to Treatment Instrument (Self-administered
paper & pencil).
Quality of Life Inventory (Self-administered paper & pencil).
BASIS–24 (Personal Interview) ...........................................
963
963
4
4
3,852
3,852
0.75
0.28
2,889
1,091
963
4
3,852
0.25
963
963
4
3,852
0.17
642
Total for Women ..........................................................
963
15,408
....................
5,585
Child Interviews/Observations
Denver Developmental Screening Inventory II (ages 0m to
6y, 0m) (Personal Interview & Observation).
CRAFFT (ages 11–17) (Personal Interview) ......................
Middle Childhood Developmental Guide (ages 6 to 10)
(Personal Interview).
Adolescent Development Guide (ages 11 to 17) (Personal
Interview).
1,926
5
9,630
0.50
4,815
1,225
657
5
5
6,125
3,285
0.17
0.33
1,021
1,095
1,225
5
6,125
0.33
2,042
Total for Children .........................................................
3,852
25,165
....................
8,973
Observation/Records Review by Staff at 8 Facilities
8
3,852 X 5
19,260
0.33
6,420
8
8
0.25
0.25
722
3,592
8
8
8
8
963 X 3
2,812 X 1 (intake)
3,852 X 3 (follow-up)
1,040 X 1
963 X 1
3,852 X 1
2,889
14,368
Newborns’ Medical Record Audit (Records Review) ..........
Women’s Discharge Tool (Records Review) ......................
Children’s Discharge Tool (Records Review) .....................
Total for Staff: ..............................................................
1,040
963
3,852
42,372
0.08
0.58
0.58
2.08
87
562
2,247
13,630
3-Year Total ..........................................................
4,823
82,945
....................
28,188
Average Annual ....................................................
cprice-sewell on PROD1PC66 with NOTICES
Child Well-Being Scales (age 0–17) (Observation &
Records Review).
Women’s Medical Record Audit (Records Review) ............
Children’s Medical Record Audit (Records Review) ...........
1,608
27,648
....................
9,396
Note: For mothers, administration of data
collection instruments will occur at: (1)
Intake, (2) 6 months post-intake, (3)
discharge, and (4) 4 months post-discharge.
For the Child Data Collection Tool, each
mother will respond for each of her estimated
4 children at intake only. For infants and
children, data collection will occur at: (1) a
time within 30 days of the mother’s intake or
the child’s birth, (2) 3 months post-intake/
birth, (3) 6 months post-intake/birth, (4)
discharge, and (5) 4 months post-discharge.
It is estimated that 27 percent (1,040) of the
children (3,852) will be delivered while the
woman is in the treatment facility. For these
infants, the Newborn’s Medical Record Audit
will be completed at delivery, and the
Children’s Medical Record Audit will be
completed at 3 months post-admission, 6
months post-admission, and at discharge.
Room 7–1044, 1 Choke Cherry Road,
Rockville, MD 20850. Written comments
should be received by January 2, 2007.
Dated: October 4, 2006.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E6–18266 Filed 10–30–06; 8:45 am]
BILLING CODE 4162–20–P
15:25 Oct 30, 2006
Jkt 211001
PO 00000
Coast Guard
[USCG–2006–26114]
National Boating Safety Activities:
Funding for National Nonprofit Public
Service Organizations
Coast Guard, DHS.
Notice of funds availability.
AGENCY:
ACTION:
SUMMARY: The Coast Guard seeks
applications for fiscal year 2007 grants
and cooperative agreements from
national, nongovernmental, nonprofit
public service organizations. The
Boating Safety Financial Assistance
Program is listed in section 97.012 of
the Catalog of Federal Domestic
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
VerDate Aug<31>2005
DEPARTMENT OF HOMELAND
SECURITY
Frm 00026
Fmt 4703
Sfmt 4703
E:\FR\FM\31OCN1.SGM
31OCN1
]]>Agencies
[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63775-63776]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18266]
-----------------------------------------------------------------------
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 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: Cross-Site Assessment of the Residential Treatment
for Pregnant and Postpartum Women (PPW) and Their Children Program--
(OMB No. 0930-0269)--Revision
The Substance Abuse and Mental Health Services Administration
(SAMHSA), Center for Substance Abuse Treatment (CSAT), is funding
additional Services Grants for Residential Treatment for Pregnant and
Postpartum Women (PPW). The purpose of the PPW is to expand the
availability of comprehensive, high quality residential treatment
services for pregnant and postpartum women who suffer from alcohol and
other drug use problems, and for their infants and children impacted by
the perinatal and environmental effects of maternal substance use and
abuse.
Section 508 [290bb-1] of the Public Health Service Act mandates the
evaluation and dissemination of findings of residential treatment
programs for pregnant and postpartum women. This cross-site
accountability assessment will assess project activities implemented
for these services.
The grantees were brought to consensus surrounding an evaluation
design and methods of data collection with accompanying instruments,
via the work of the project officer and consultant experts in the
field. The data collection instruments will be used for program and
treatment planning, local evaluations, and for this cross-site
accountability evaluation. For mothers, administration of data
collection instruments will occur at intake, 6 months post-intake,
discharge, and 4 months post-discharge.\1\ The following four different
interview instruments will be used for mothers:
---------------------------------------------------------------------------
\1\ The 4 month post-discharge administration replaces the 12-
month post-admission administration approved by OMB for the pilot
study. This modification was made because it is believed that post-
discharge followup information will be more informative and will
have more cases than 12 months post-admission.
---------------------------------------------------------------------------
1. Child Data Collection Tool, Part 1 (child's personal background)
and Part 2 (child's medical background);
2. Ferrans and Powers Quality of Life Index(copyright) Generic
Version--III;
3. BASIS-24[supreg] (pilot study used BASIS-32[supreg])--behavioral
health assessment; and
4. Allen Barriers to Treatment Instrument.
For all children under 18 years, program staff will collect
information from observation, interview, and records review. For
infants and children, data collection will occur at a time within 30
days of the mother's intake or the child's birth, 3 months post-intake/
birth, 6 months post-intake/birth, discharge, and 4 months post-
discharge.\1\ Children's data collection tools include the following:
1. Child Well-Being Scales (staff observation and records review
for all children);
2. Denver Developmental Screening Inventory II (ages 0 to 6 years,
0 days);
3. Middle Childhood Developmental Assessment Guide (ages 6 to 10);
4. Adolescent Childhood Development Assessment Guide (ages 11 to
17); and
5. CRAFFT substance abuse screening instrument (ages 11-17).
In addition, records review will be conducted by program staff on
all program participants. First, at each data collection period except
for 4 months post-discharge, staff will complete the Women's Medical
Record Audit and the Child's Medical Record Audit (or the Newborn's
Medical Record Audit at delivery.) Second, staff will complete the
Women's Discharge Tool and the Children's Discharge Tool at discharge.
[[Page 63776]]
All data will be collected using a combination of observation,
records review, self-administered paper-and-pencil questionnaires, and
personal interviews. CSAT will use this data for this evaluation to
inform public policy, research, and programming as they relate to the
provision of women's services. Data produced by this study will provide
direction to the type of technical assistance that will be required by
service providers of women's programming. In addition, the data will be
used by individual grantees to support progress report efforts.
The following table shows the estimated annual response burden for
this collection.
Estimates of Burden Hours
----------------------------------------------------------------------------------------------------------------
Form name/type of Number of Total Hours per Total hour
administration respondents Responses per respondent responses response burden
----------------------------------------------------------------------------------------------------------------
Women Interviews
----------------------------------------------------------------------------------------------------------------
Child Data Collection Tool 963 4 3,852 0.75 2,889
(Personal Interview).
Allen Barriers to Treatment 963 4 3,852 0.28 1,091
Instrument (Self-
administered paper &
pencil).
Quality of Life Inventory 963 4 3,852 0.25 963
(Self-administered paper &
pencil).
BASIS-24 (Personal 963 4 3,852 0.17 642
Interview).
-----------------------------------------------------------------------------------
Total for Women......... 963 .............................. 15,408 ........... 5,585
----------------------------------------------------------------------------------------------------------------
Child Interviews/Observations
----------------------------------------------------------------------------------------------------------------
Denver Developmental 1,926 5 9,630 0.50 4,815
Screening Inventory II
(ages 0m to 6y, 0m)
(Personal Interview &
Observation).
CRAFFT (ages 11-17) 1,225 5 6,125 0.17 1,021
(Personal Interview).
Middle Childhood 657 5 3,285 0.33 1,095
Developmental Guide (ages 6
to 10) (Personal Interview).
Adolescent Development Guide 1,225 5 6,125 0.33 2,042
(ages 11 to 17) (Personal
Interview).
-----------------------------------------------------------------------------------
Total for Children...... 3,852 .............................. 25,165 ........... 8,973
----------------------------------------------------------------------------------------------------------------
Observation/Records Review by Staff at 8 Facilities
----------------------------------------------------------------------------------------------------------------
Child Well-Being Scales (age 8 3,852 X 5 19,260 0.33 6,420
0-17) (Observation &
Records Review).
Women's Medical Record Audit 8 963 X 3 2,889 0.25 722
(Records Review).
Children's Medical Record 8 2,812 X 1 (intake) 14,368 0.25 3,592
Audit (Records Review). 3,852 X 3 (follow-up)
Newborns' Medical Record 8 1,040 X 1 1,040 0.08 87
Audit (Records Review).
Women's Discharge Tool 8 963 X 1 963 0.58 562
(Records Review).
Children's Discharge Tool 8 3,852 X 1 3,852 0.58 2,247
(Records Review).
Total for Staff:........ 8 .............................. 42,372 2.08 13,630
-----------------------------------------------------------------------------------
3-Year Total........ 4,823 .............................. 82,945 ........... 28,188
-----------------------------------------------------------------------------------
Average Annual...... 1,608 .............................. 27,648 ........... 9,396
----------------------------------------------------------------------------------------------------------------
Note: For mothers, administration of data collection instruments
will occur at: (1) Intake, (2) 6 months post-intake, (3) discharge,
and (4) 4 months post-discharge. For the Child Data Collection Tool,
each mother will respond for each of her estimated 4 children at
intake only. For infants and children, data collection will occur
at: (1) a time within 30 days of the mother's intake or the child's
birth, (2) 3 months post-intake/birth, (3) 6 months post-intake/
birth, (4) discharge, and (5) 4 months post-discharge. It is
estimated that 27 percent (1,040) of the children (3,852) will be
delivered while the woman is in the treatment facility. For these
infants, the Newborn's Medical Record Audit will be completed at
delivery, and the Children's Medical Record Audit will be completed
at 3 months post-admission, 6 months post-admission, and at
discharge.
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, 1 Choke Cherry Road, Rockville, MD 20850. Written comments
should be received by January 2, 2007.
Dated: October 4, 2006.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E6-18266 Filed 10-30-06; 8:45 am]
BILLING CODE 4162-20-P
