Federal Register / Vol. 72, No. 13 / Monday, January 22, 2007 / Notices 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 

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 http:// 

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 


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