42644 Federal Register / Vol. 71, No.

144 / Thursday, July 27, 2006 / Notices

ESTIMATE OF ANNUALIZED BURDEN HOURS

Average
Number of
Number of burden per Total burden
Respondents responses per
respondents response (in hours)
respondent (in hours)

Women-Screening interview ............................................................................ 55 1 10/60 10

Women-Focus groups ..................................................................................... 32 1 2 64
Women-individual interviews ........................................................................... 20 1 2 40
Community leaders-Focus groups ................................................................... 32 1 2 64

Total .......................................................................................................... ........................ ........................ ........................ 178

Dated: July 21, 2006. clarity of the information to be health care providers could play in
Joan F. Karr, collected; and (d) ways to minimize the reducing its serious consequences,
Acting Reports Clearance Officer, Centers for burden of the collection of information numerous professional and health care
Disease Control and Prevention. on respondents, including through the organizations have recommended
[FR Doc. E6–12023 Filed 7–26–06; 8:45 am] use of automated collection techniques routine screening of women for IPV in
BILLING CODE 4163–18–P or other forms of information primary care settings. However, various
technology. Written comments should systematic reviews of the literature have
be received within 60 days of this not found evidence for the effectiveness
DEPARTMENT OF HEALTH AND notice. of screening to improve outcomes for
HUMAN SERVICES women exposed to IPV.
Proposed Project
A recent expert panel recommended
Centers for Disease Control and Randomized Controlled Trial of that a randomized controlled trial (RCT)
Prevention Routine Screening for Intimate Partner be conducted to establish the
[60Day–06–06BM] Violence—New—National Center for effectiveness of screening on women’s
Injury Prevention and Control (NCIPC), health. In order to appropriately design
Proposed Data Collections Submitted Centers for Disease Control and a RCT, estimates of health change are
for Public Comment and Prevention (CDC). required to calculate the sample size for
Recommendations the RCT, and consequently, establish its
Background and Brief Description
In compliance with the requirement cost. In addition, the feasibility,
of Section 3506(c)(2)(A) of the Intimate partner violence (IPV) is a acceptability, and impact of different
Paperwork Reduction Act of 1995 for prevalent problem with serious health approaches to screening and the
opportunity for public comment on consequences that include death, concordance of different data collection
proposed data collection projects, the physical injury, increased rates of methods need to be assessed to
Centers for Disease Control and physical illness, posttraumatic stress, adequately design the RCT.
Prevention (CDC) will publish periodic increased psychological distress, CDC has a contract to pilot test
summaries of proposed projects. To depression, substance abuse, and measures and procedures that are being
request more information on the suicide. Some studies suggest that abuse proposed for a RCT of routine screening
proposed projects or to obtain a copy of perpetrated by intimate partners tends of IPV. This pilot test will recruit 175
the data collection plans and to be repetitive and escalates in severity women from OBGYN and family
instruments, call 404–639–5960 and over time. This research has been the planning services in Cook County
send comments to Seleda Perryman, basis for promoting early diagnosis and Hospital in Chicago. Women who agree
CDC Assistant Reports Clearance intervention. to participate will be asked to complete
Officer, 1600 Clifton Road, MS–D74, Health care providers appear to be a baseline computer-assisted and one
Atlanta, GA 30333 or send an e-mail to well situated to identify IPV. Women week follow-up telephone questionnaire
omb@cdc.gov. come into contact with health care that will include overall health,
Comments are invited on: (a) Whether services routinely for a number of physical and mental health, disability,
the proposed collection of information reasons such as prenatal care, family health care utilization, and quality of
is necessary for the proper performance planning, cancer screening, and well life (QOL). Based on this pilot test, the
of the functions of the agency, including baby care. Women experiencing IPV measure will be revised and used in a
whether the information shall have make more visits to emergency RCT with 3000 women to test the
practical utility; (b) the accuracy of the departments, primary care facilities, and impact of screening on health and QOL.
agency’s estimate of the burden of the mental health agencies than non-abused There are no costs to respondents other
proposed collection of information; (c) women. Considering the magnitude and than their time to participate in the
ways to enhance the quality, utility, and severity of IPV, and the potential role survey.

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Avg. burden/
Number of Total burden
Form responses per response
respondents (hours)
respondents (in hours)
rwilkins on PROD1PC63 with NOTICES

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

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 Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices 42645

ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Number of Avg. burden/
Number of Total burden
Form responses per response
respondents (hours)
respondents (in hours)

Health and QOL questionnaire Final ............................................................... 3000 2 20/60 2000

Total .......................................................................................................... ........................ ........................ ........................ 2184

Dated: July 21, 2006. Dated: July 20, 2006. (HFZ–220), Center for Devices and
Joan F. Karr, Alvin Hall, Radiological Health, Food and Drug
Acting Reports Clearance Officer, Centers for Director, Management Analysis and Services Administration, 1350 Piccard Dr.,
Disease Control and Prevention. Office, Centers for Disease Control and Rockville, MD 20850. Send one self-
[FR Doc. E6–12025 Filed 7–26–06; 8:45 am] Prevention. addressed adhesive label to assist that
BILLING CODE 4163–18–P [FR Doc. E6–12015 Filed 7–26–06; 8:45 am] office in processing your request, or fax
BILLING CODE 4163–18–P your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION section for
DEPARTMENT OF HEALTH AND information on electronic access to the
HUMAN SERVICES DEPARTMENT OF HEALTH AND guidance.
HUMAN SERVICES Submit written comments concerning
Centers for Disease Control and this guidance to the Division of Dockets
Prevention Food and Drug Administration Management (HFA–305), Food and Drug
[Docket No. 2006D–0275] Administration, 5630 Fishers Lane, rm.
Disease, Disability, and Injury 1061, Rockville, MD 20852. Submit
Prevention and Control Special Guidance for Industry and Food and electronic comments to http://
Emphasis Panel (SEP): CDC Public Drug Administration Staff; Class II www.fda.gov/dockets/ecomments.
Health Research: Health Protection Special Controls Guidance Document: Identify comments with the docket
Research Initiative Graduate Training Fecal Calprotectin Immunological Test number found in brackets in the
Program Grant, Request for Systems; Availability heading of this document.
Applications (RFA) CD07–001 FOR FURTHER INFORMATION CONTACT:
AGENCY: Food and Drug Administration, Deborah Moore, Center for Devices and
In accordance with section 10(a)(2) of HHS. Radiological Health (HFZ–440), Food
the Federal Advisory Committee Act ACTION: Notice. and Drug Administration, 2098 Gaither
(Pub. L. 92–463), the Centers for Disease Rd., Rockville, MD 20850, 240–276–
Control and Prevention (CDC) SUMMARY: The Food and Drug
0493.
announces the following meeting: Administration (FDA) is announcing the
availability of the guidance entitled SUPPLEMENTARY INFORMATION:
Name: Disease, Disability, and Injury
‘‘Class II Special Controls Guidance I. Background
Prevention and Control Special Emphasis
Panel (SEP): CDC Public Health Research:
Document: Fecal Calprotectin
Immunological Test Systems.’’ This Elsewhere in this issue of the Federal
Health Protection Research Initiative Register, FDA is publishing a final rule
Graduate Training Program Grant, Request guidance document describes a means
by which fecal calprotectin classifying fecal calprotectin
for Applications (RFA) CD07–001.
immunological test systems may comply immunological test systems into class II
Time and Date: 12 p.m.–4 p.m., September
14, 2006 (Closed). with the requirement of special controls (special controls) under section 513(f)(2)
Place: Teleconference. for class II devices. Elsewhere in this of the Federal Food, Drug, and Cosmetic
Status: The meeting will be closed to the issue of the Federal Register, FDA is Act (the act) (21 U.S.C. 360c(f)(2)). This
public in accordance with provisions set publishing a final rule to classify fecal notice announces the guidance
forth in Section 552b(c)(4) and (6), Title 5
calprotectin immunological test systems document that will serve as the special
U.S.C., and the Determination of the Director, control for fecal calprotectin
Management Analysis and Services Office,
into class II (special controls). This
guidance document is immediately in immunological test systems.
CDC, pursuant to Public Law 92–463. Section 513(f)(2) of the act provides
Matters To Be Discussed: The meeting will effect as the special control for fecal
that any person who submits a
include the review, discussion, and calprotectin immunological test
premarket notification under section
evaluation of applications received in systems, but it remains subject to
510(k) of the act (21 U.S.C. 360(k)) for
response to RFA CD07–001, ‘‘CDC Public comment in accordance with the
Health Research: Health Protection Research a device that has not previously been
agency’s good guidance practices
Initiative Graduate Training Program Grant.’’ classified may, within 30 days after
(GGPs).
Contact Person For More Information: receiving an order classifying the device
Christine Morrison, PhD., Scientific Review DATES: Submit written or electronic in class III under section 513(f)(1) of the
Administrator, Office of Extramural comments on this guidance at any time. act, request FDA to classify the device
Research, CDC, 1600 Clifton Road, NE., General comments on agency guidance under the criteria set forth in section
Mailstop D72, Atlanta, GA 30333, Telephone documents are welcome at any time. 513(a)(1) of the act. FDA shall, within
404.639.3098. ADDRESSES: Submit written requests for 60 days of receiving such a request,
The Director, Management Analysis and single copies of the guidance document classify the device by written order.
rwilkins on PROD1PC63 with NOTICES

Services Office, has been delegated the

authority to sign Federal Register notices
entitled ‘‘Class II Special Controls This classification shall be the initial
pertaining to announcements of meetings and Guidance Document: Fecal Calprotectin, classification of the device. Within 30
other committee management activities, for Immunological Test Systems’’ to the days after the issuance of an order
both CDC and the Agency for Toxic Division of Small Manufacturers, classifying the device, FDA must
Substances and Disease Registry. International, and Consumer Assistance publish a notice in the Federal Register

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