Review of Diagnostic Tests Available for the Detection of Tuberculosis in Imported Nonhuman Primates Undergoing Federal Quarantine, 2698-2699 [E7-794]
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2698
Federal Register / Vol. 72, No. 13 / Monday, January 22, 2007 / Notices
type. Large schools will be given the
option to invite a census of ninth grade
students to participate in the study or to
invite a subset of ninth grade students
(in certain classes) to participate.
Schools within a set of three will be
matched on census versus subset
selection of ninth graders to ensure that
all schools in a set use the same
selection process. Eighteen matched sets
of three schools will be selected. One
school from each matched set will be
assigned randomly either to receive the
Safe Dates program with teacher
training and observation, to receive the
Safe Dates program without teacher
training and observation, or to serve as
a control group.
Approximately 10,158 students at the
54 schools will complete a baseline
effectiveness evaluation scannable
survey. During the classroomadministered survey, information will
be collected from students about how
they feel about dating, communicating
with a dating partner, and attitudes and
behaviors related to violence, including
violence between preteen and teen
dating couples. Informed written
consent from parents for their child’s
participation and informed written
assent from ninth graders for their own
participation will be obtained. During
Web surveys, school staff will be asked
about implementation and costs of the
Safe Dates program.
Effectiveness evaluation baseline data
collection will span the period from
October to November 2007, and followup data collection will occur during
January and February 2009. Assuming
an 80 percent response rate at followup, it is anticipated that a total of 8,126
students will complete follow-up
effectiveness evaluation surveys.
To evaluate the implementation and
implementation drivers of the program,
principals and prevention coordinators
at all 54 schools will be asked to
complete a series of Web surveys from
October 2007 to February 2009.
Assuming a 91 percent response rate for
all school staff surveys, it is anticipated
that 48 principals and 48 prevention
coordinators will complete baseline
implementation questionnaires, 32
principals and 32 prevention
coordinators at treatment schools will
complete mid-implementation
questionnaires, 48 principals will
complete end-of-school year
implementation questionnaires, and 48
prevention coordinators will complete
follow-up implementation
questionnaires. In addition, 97 teachers
at treatment schools will complete Web
baseline implementation questionnaires,
48 teachers at treatment schools
receiving training and observation will
complete cost questionnaires, and 97
teachers at treatment schools will
complete two mid-implementation
questionnaires each. Students at
treatment schools (n=5,417) will also
complete two mid-implementation
questionnaires each.
It is anticipated that study results will
be used to determine the Safe Dates
program’s effectiveness, economic and
time costs, cost-effectiveness, costutility, feasibility of implementation,
dissemination facilitators, and needed
improvements for implementation with
fidelity.
There are no costs to respondents
except their time to participate in the
interview.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Instrument name
Responses/respondent
Hours/response
Total response
burden
(Hours)
Student effectiveness baseline survey ............................................
Principal baseline implementation survey .......................................
Prevention coordinator baseline implementation survey .................
Teacher baseline implementation survey ........................................
Principal mid-implementation survey ...............................................
Prevention coordinator mid-implementation survey ........................
Teacher cost survey ........................................................................
First teacher mid-implementation survey .........................................
Second teacher mid-implementation survey ...................................
First student mid-implementation survey .........................................
Second student mid-implementation survey ....................................
Principal end-of-school-year implementation survey .......................
Student effectiveness follow-up survey ...........................................
Prevention coordinator follow-up implementation survey ................
10,158
48
48
97
32
32
48
97
97
5,417
5,417
48
8,126
48
1
1
1
1
1
1
11
2
2
2
2
1
1
1
50/60
10/60
10/60
10/60
10/60
15/60
20/60
15/60
15/60
25/60
25/60
10/60
50/60
10/60
8,465
8
8
16
5
8
176
48
48
4,514
4,514
8
6,772
8
Total ..........................................................................................
29,713
............................
............................
24,598
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
rmajette on PROD1PC67 with NOTICES
Dated: January 11, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–773 Filed 1–19–07; 8:45 am]
Review of Diagnostic Tests Available
for the Detection of Tuberculosis in
Imported Nonhuman Primates
Undergoing Federal Quarantine
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention, Department of Health and
Human Services.
AGENCY:
ACTION:
VerDate Aug<31>2005
15:20 Jan 19, 2007
Jkt 211001
PO 00000
Notice of public meeting.
Frm 00052
Fmt 4703
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SUMMARY: This notice announces a
public meeting on the subject of
tuberculosis detection in imported
nonhuman primates. The purpose of the
meeting is to review current Institute of
Laboratory Animal Research
recommendations and compare newer
diagnostic tests available for
tuberculosis testing in nonhuman
primates.
DATES: The public meeting will be held
February 16, 2007, from 12:30 p.m. to
4:30 p.m. in Atlanta, Georgia.
Registration will begin at 11 a.m.
ADDRESSES: The public meeting will be
held at the following location: Centers
E:\FR\FM\22JAN1.SGM
22JAN1
Federal Register / Vol. 72, No. 13 / Monday, January 22, 2007 / Notices
for Disease Control and Prevention,
1600 Clifton Road, Atlanta, GA 30333,
Building 19 Auditorium A.
FOR FURTHER INFORMATION, CONTACT:
Zoonoses Team, telephone 404–639–
3441; ggg0@cdc.gov; fax 404–639–4441;
Division of Global Migration and
Quarantine, CDC.
SUPPLEMENTARY INFORMATION:
Participation at the Public Meeting
Pre-registration is recommended.
Because the meeting will be held at
CDC’s secure facility, non-U.S. citizens
will be required to undergo a
background check in order to attend.
For individuals who are not U.S.
citizens, the following information must
be provided to the Zoonosis Team at
least 15 days in advance:
rmajette on PROD1PC67 with NOTICES
Individual’s Full Name (official):
Gender:
Date of Birth:
Place of Birth (city, province, state, country):
Country of Citizenship:
Passport Type and Number:
Date of Passport Issue:
Date of Passport Expiration:
Type of Visa and Expiration Date:
—If the visitor is a Permanent Resident of
the U.S., provide Permanent Resident #
Visitor’s Organization:
Visitor’s Position/Title within the
Organization:
Visitor’s Organization Address:
Visitor’s Organization Telephone Number:
Background
The presence of tuberculosis in
nonhuman primates may pose a
substantial health risk to caretakers and
interfere with or interrupt research.
Tuberculosis infections in nonhuman
primates may have few outward
symptoms, and testing of animals is
usually needed to determine infection.
Because of the public health risks
associated with tuberculosis, nonhuman
primates imported into the United
States must be quarantined for a
minimum of 31 days and have 3
negative tuberculosis skin tests
performed at 2-week intervals in
accordance with the Institute of
Laboratory Animal Research (ILAR;
formerly the Institute of Laboratory
Animal Resources) guidelines that were
published in 1980. The current accepted
test for tuberculosis in nonhuman
primates is the tuberculin skin test
(TST) using Mammalian Old
Tuberculin. The sensitivity and
specificity of this test are not ideal.
Since 1999, 1 to 54 cases of tuberculosis
have been reported in imported
nonhuman primates each year. In some
cases, animals had multiple negative
TSTs before a positive TST was noted.
A few of the cases had negative TST
results through the 31-day quarantine
VerDate Aug<31>2005
15:20 Jan 19, 2007
Jkt 211001
period and then had a positive TST after
release from quarantine, thus
jeopardizing research or colonies into
which the animals were introduced.
Since the publication of the 1980
ILAR guidelines, several alternative
diagnostic tests have been developed.
The purpose of this meeting is to
discuss available alternatives to the
TST; compare test results with
alternative tuberculosis detection
methods; and generate interest in a
formal review of new diagnostics for
tuberculosis testing of nonhuman
primates.
2699
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0019]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry and Food and
Drug Administration Staff on Class II
Special Controls Guidance Document:
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle
Public Meeting Procedures
The following procedures will be in
place for this meeting:
1. Admission and participation in the
public meeting are free. The meeting
will be open to all persons.
2. Representatives from the CDC will
conduct the public meeting. Experts on
nonhuman primate importation,
tuberculosis diagnostic testing in
nonhuman primates, and ILAR
guidelines will give presentations.
3. The public meeting is intended as
a forum to share information and
answer questions concerning
tuberculosis testing in nonhuman
primates.
4. All interested parties will have the
opportunity to ask questions or make
short comments regarding diagnostic
tests for tuberculosis in nonhuman
primates.
5. Statements made by CDC personnel
and other federal personnel are
intended to facilitate discussion of the
issues or to clarify issues. Such
statements should not be interpreted as
providing legal, professional, or other
advice.
6. The meeting is designed to share
information and solicit individual views
from the public. The meeting will not
operate in consensus fashion. The
meeting will be conducted in an
informal and non-adversarial manner.
Dated: January 16, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–794 Filed 1–19–07; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff on Class II
Special Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of June 2, 2006 (71 FR
32101), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0594. The
approval expires on September 30,
2009. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: January 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–804 Filed 1–19–07; 8:45 am]
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PO 00000
AGENCY:
BILLING CODE 4160–01–S
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Fmt 4703
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22JAN1
Agencies
[Federal Register Volume 72, Number 13 (Monday, January 22, 2007)]
[Notices]
[Pages 2698-2699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-794]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Review of Diagnostic Tests Available for the Detection of
Tuberculosis in Imported Nonhuman Primates Undergoing Federal
Quarantine
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces a public meeting on the subject of
tuberculosis detection in imported nonhuman primates. The purpose of
the meeting is to review current Institute of Laboratory Animal
Research recommendations and compare newer diagnostic tests available
for tuberculosis testing in nonhuman primates.
DATES: The public meeting will be held February 16, 2007, from 12:30
p.m. to 4:30 p.m. in Atlanta, Georgia. Registration will begin at 11
a.m.
ADDRESSES: The public meeting will be held at the following location:
Centers
[[Page 2699]]
for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA
30333, Building 19 Auditorium A.
FOR FURTHER INFORMATION, CONTACT: Zoonoses Team, telephone 404-639-
3441; ggg0@cdc.gov; fax 404-639-4441; Division of Global Migration and
Quarantine, CDC.
SUPPLEMENTARY INFORMATION:
Participation at the Public Meeting
Pre-registration is recommended. Because the meeting will be held
at CDC's secure facility, non-U.S. citizens will be required to undergo
a background check in order to attend. For individuals who are not U.S.
citizens, the following information must be provided to the Zoonosis
Team at least 15 days in advance:
Individual's Full Name (official):
Gender:
Date of Birth:
Place of Birth (city, province, state, country):
Country of Citizenship:
Passport Type and Number:
Date of Passport Issue:
Date of Passport Expiration:
Type of Visa and Expiration Date:
--If the visitor is a Permanent Resident of the U.S., provide
Permanent Resident
Visitor's Organization:
Visitor's Position/Title within the Organization:
Visitor's Organization Address:
Visitor's Organization Telephone Number:
Background
The presence of tuberculosis in nonhuman primates may pose a
substantial health risk to caretakers and interfere with or interrupt
research. Tuberculosis infections in nonhuman primates may have few
outward symptoms, and testing of animals is usually needed to determine
infection. Because of the public health risks associated with
tuberculosis, nonhuman primates imported into the United States must be
quarantined for a minimum of 31 days and have 3 negative tuberculosis
skin tests performed at 2-week intervals in accordance with the
Institute of Laboratory Animal Research (ILAR; formerly the Institute
of Laboratory Animal Resources) guidelines that were published in 1980.
The current accepted test for tuberculosis in nonhuman primates is the
tuberculin skin test (TST) using Mammalian Old Tuberculin. The
sensitivity and specificity of this test are not ideal. Since 1999, 1
to 54 cases of tuberculosis have been reported in imported nonhuman
primates each year. In some cases, animals had multiple negative TSTs
before a positive TST was noted. A few of the cases had negative TST
results through the 31-day quarantine period and then had a positive
TST after release from quarantine, thus jeopardizing research or
colonies into which the animals were introduced.
Since the publication of the 1980 ILAR guidelines, several
alternative diagnostic tests have been developed. The purpose of this
meeting is to discuss available alternatives to the TST; compare test
results with alternative tuberculosis detection methods; and generate
interest in a formal review of new diagnostics for tuberculosis testing
of nonhuman primates.
Public Meeting Procedures
The following procedures will be in place for this meeting:
1. Admission and participation in the public meeting are free. The
meeting will be open to all persons.
2. Representatives from the CDC will conduct the public meeting.
Experts on nonhuman primate importation, tuberculosis diagnostic
testing in nonhuman primates, and ILAR guidelines will give
presentations.
3. The public meeting is intended as a forum to share information
and answer questions concerning tuberculosis testing in nonhuman
primates.
4. All interested parties will have the opportunity to ask
questions or make short comments regarding diagnostic tests for
tuberculosis in nonhuman primates.
5. Statements made by CDC personnel and other federal personnel are
intended to facilitate discussion of the issues or to clarify issues.
Such statements should not be interpreted as providing legal,
professional, or other advice.
6. The meeting is designed to share information and solicit
individual views from the public. The meeting will not operate in
consensus fashion. The meeting will be conducted in an informal and
non-adversarial manner.
Dated: January 16, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-794 Filed 1-19-07; 8:45 am]
BILLING CODE 4163-18-P