Proposed Data Collections Submitted for Public Comment and Recommendations, 42644-42645 [E6-12025]
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42644
Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Women-Screening interview ............................................................................
Women-Focus groups .....................................................................................
Women-individual interviews ...........................................................................
Community leaders-Focus groups ...................................................................
55
32
20
32
1
1
1
1
10/60
2
2
2
10
64
40
64
Total ..........................................................................................................
........................
........................
........................
178
Dated: July 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–12023 Filed 7–26–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
health care providers could play in
reducing its serious consequences,
numerous professional and health care
organizations have recommended
routine screening of women for IPV in
primary care settings. However, various
systematic reviews of the literature have
not found evidence for the effectiveness
of screening to improve outcomes for
women exposed to IPV.
A recent expert panel recommended
that a randomized controlled trial (RCT)
be conducted to establish the
effectiveness of screening on women’s
health. In order to appropriately design
a RCT, estimates of health change are
required to calculate the sample size for
the RCT, and consequently, establish its
cost. In addition, the feasibility,
acceptability, and impact of different
approaches to screening and the
concordance of different data collection
methods need to be assessed to
adequately design the RCT.
CDC has a contract to pilot test
measures and procedures that are being
proposed for a RCT of routine screening
of IPV. This pilot test will recruit 175
women from OBGYN and family
planning services in Cook County
Hospital in Chicago. Women who agree
to participate will be asked to complete
a baseline computer-assisted and one
week follow-up telephone questionnaire
that will include overall health,
physical and mental health, disability,
health care utilization, and quality of
life (QOL). Based on this pilot test, the
measure will be revised and used in a
RCT with 3000 women to test the
impact of screening on health and QOL.
There are no costs to respondents other
than their time to participate in the
survey.
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Centers for Disease Control and
Prevention
[60Day–06–06BM]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
Randomized Controlled Trial of
Routine Screening for Intimate Partner
Violence—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Intimate partner violence (IPV) is a
prevalent problem with serious health
consequences that include death,
physical injury, increased rates of
physical illness, posttraumatic stress,
increased psychological distress,
depression, substance abuse, and
suicide. Some studies suggest that abuse
perpetrated by intimate partners tends
to be repetitive and escalates in severity
over time. This research has been the
basis for promoting early diagnosis and
intervention.
Health care providers appear to be
well situated to identify IPV. Women
come into contact with health care
services routinely for a number of
reasons such as prenatal care, family
planning, cancer screening, and well
baby care. Women experiencing IPV
make more visits to emergency
departments, primary care facilities, and
mental health agencies than non-abused
women. Considering the magnitude and
severity of IPV, and the potential role
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
rwilkins on PROD1PC63 with NOTICES
Form
Screener for Pilot .............................................................................................
Pilot Health and QOL questionnaire ................................................................
Screener for Final Pilot ....................................................................................
VerDate Aug<31>2005
16:46 Jul 26, 2006
Jkt 208001
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Number of
responses per
respondents
210
175
3750
E:\FR\FM\27JYN1.SGM
1
2
1
27JYN1
Avg. burden/
response
(in hours)
1/60
20/60
1/60
Total burden
(hours)
4
117
63
42645
Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondents
Number of
respondents
Form
Avg. burden/
response
(in hours)
Total burden
(hours)
Health and QOL questionnaire Final ...............................................................
3000
2
20/60
2000
Total ..........................................................................................................
........................
........................
........................
2184
Dated: July 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–12025 Filed 7–26–06; 8:45 am]
BILLING CODE 4163–18–P
Dated: July 20, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–12015 Filed 7–26–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
[Docket No. 2006D–0275]
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
rwilkins on PROD1PC63 with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): CDC Public
Health Research: Health Protection
Research Initiative Graduate Training
Program Grant, Request for
Applications (RFA) CD07–001
HHS.
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): CDC Public Health Research:
Health Protection Research Initiative
Graduate Training Program Grant, Request
for Applications (RFA) CD07–001.
Time and Date: 12 p.m.–4 p.m., September
14, 2006 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to RFA CD07–001, ‘‘CDC Public
Health Research: Health Protection Research
Initiative Graduate Training Program Grant.’’
Contact Person For More Information:
Christine Morrison, PhD., Scientific Review
Administrator, Office of Extramural
Research, CDC, 1600 Clifton Road, NE.,
Mailstop D72, Atlanta, GA 30333, Telephone
404.639.3098.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
VerDate Aug<31>2005
16:46 Jul 26, 2006
Jkt 208001
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Fecal Calprotectin Immunological Test
Systems; Availability
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Class II Special Controls Guidance
Document: Fecal Calprotectin
Immunological Test Systems.’’ This
guidance document describes a means
by which fecal calprotectin
immunological test systems may comply
with the requirement of special controls
for class II devices. Elsewhere in this
issue of the Federal Register, FDA is
publishing a final rule to classify fecal
calprotectin immunological test systems
into class II (special controls). This
guidance document is immediately in
effect as the special control for fecal
calprotectin immunological test
systems, but it remains subject to
comment in accordance with the
agency’s good guidance practices
(GGPs).
Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Class II Special Controls
Guidance Document: Fecal Calprotectin,
Immunological Test Systems’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
DATES:
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. 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.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Deborah Moore, Center for Devices and
Radiological Health (HFZ–440), Food
and Drug Administration, 2098 Gaither
Rd., Rockville, MD 20850, 240–276–
0493.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying fecal calprotectin
immunological test systems into class II
(special controls) under section 513(f)(2)
of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360c(f)(2)). This
notice announces the guidance
document that will serve as the special
control for fecal calprotectin
immunological test systems.
Section 513(f)(2) of the act provides
that any person who submits a
premarket notification under section
510(k) of the act (21 U.S.C. 360(k)) for
a device that has not previously been
classified may, within 30 days after
receiving an order classifying the device
in class III under section 513(f)(1) of the
act, request FDA to classify the device
under the criteria set forth in section
513(a)(1) of the act. FDA shall, within
60 days of receiving such a request,
classify the device by written order.
This classification shall be the initial
classification of the device. Within 30
days after the issuance of an order
classifying the device, FDA must
publish a notice in the Federal Register
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 71, Number 144 (Thursday, July 27, 2006)]
[Notices]
[Pages 42644-42645]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-06-06BM]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Randomized Controlled Trial of Routine Screening for Intimate
Partner Violence--New--National Center for Injury Prevention and
Control (NCIPC), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Intimate partner violence (IPV) is a prevalent problem with serious
health consequences that include death, physical injury, increased
rates of physical illness, posttraumatic stress, increased
psychological distress, depression, substance abuse, and suicide. Some
studies suggest that abuse perpetrated by intimate partners tends to be
repetitive and escalates in severity over time. This research has been
the basis for promoting early diagnosis and intervention.
Health care providers appear to be well situated to identify IPV.
Women come into contact with health care services routinely for a
number of reasons such as prenatal care, family planning, cancer
screening, and well baby care. Women experiencing IPV make more visits
to emergency departments, primary care facilities, and mental health
agencies than non-abused women. Considering the magnitude and severity
of IPV, and the potential role health care providers could play in
reducing its serious consequences, numerous professional and health
care organizations have recommended routine screening of women for IPV
in primary care settings. However, various systematic reviews of the
literature have not found evidence for the effectiveness of screening
to improve outcomes for women exposed to IPV.
A recent expert panel recommended that a randomized controlled
trial (RCT) be conducted to establish the effectiveness of screening on
women's health. In order to appropriately design a RCT, estimates of
health change are required to calculate the sample size for the RCT,
and consequently, establish its cost. In addition, the feasibility,
acceptability, and impact of different approaches to screening and the
concordance of different data collection methods need to be assessed to
adequately design the RCT.
CDC has a contract to pilot test measures and procedures that are
being proposed for a RCT of routine screening of IPV. This pilot test
will recruit 175 women from OBGYN and family planning services in Cook
County Hospital in Chicago. Women who agree to participate will be
asked to complete a baseline computer-assisted and one week follow-up
telephone questionnaire that will include overall health, physical and
mental health, disability, health care utilization, and quality of life
(QOL). Based on this pilot test, the measure will be revised and used
in a RCT with 3000 women to test the impact of screening on health and
QOL. There are no costs to respondents other than their time to
participate in the survey.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden/
Form Number of responses per response (in Total burden
respondents respondents hours) (hours)
----------------------------------------------------------------------------------------------------------------
Screener for Pilot.............................. 210 1 1/60 4
Pilot Health and QOL questionnaire.............. 175 2 20/60 117
Screener for Final Pilot........................ 3750 1 1/60 63
[[Page 42645]]
Health and QOL questionnaire Final.............. 3000 2 20/60 2000
---------------------------------------------------------------
Total....................................... .............. .............. .............. 2184
----------------------------------------------------------------------------------------------------------------
Dated: July 21, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-12025 Filed 7-26-06; 8:45 am]
BILLING CODE 4163-18-P
