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, 2699 [E7-804]
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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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[Federal Register Volume 72, Number 13 (Monday, January 22, 2007)]
[Notices]
[Page 2699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-804]
-----------------------------------------------------------------------
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
AGENCY: 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.
SUPPLEMENTARY INFORMATION: 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.
Dated: January 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-804 Filed 1-19-07; 8:45 am]
BILLING CODE 4160-01-S
