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

Instrument name Number of respondents 

Responses/respondent Hours/response 

Total response 

burden 

(Hours) 

Student effectiveness baseline survey ............................................ 10,158 1 50/60 8,465 

Principal baseline implementation survey ....................................... 48 1 10/60 8 

Prevention coordinator baseline implementation survey ................. 48 1 10/60 8 

Teacher baseline implementation survey ........................................ 97 1 10/60 16 

Principal mid-implementation survey ............................................... 32 1 10/60 5 

Prevention coordinator mid-implementation survey ........................ 32 1 15/60 8 

Teacher cost survey ........................................................................ 48 11 20/60 176 

First teacher mid-implementation survey ......................................... 97 2 15/60 48 

Second teacher mid-implementation survey ................................... 97 2 15/60 48 

First student mid-implementation survey ......................................... 5,417 2 25/60 4,514 

Second student mid-implementation survey .................................... 5,417 2 25/60 4,514 

Principal end-of-school-year implementation survey ....................... 48 1 10/60 8 

Student effectiveness follow-up survey ........................................... 8,126 1 50/60 6,772 

Prevention coordinator follow-up implementation survey ................ 48 1 10/60 8 

Total .......................................................................................... 29,713 ............................ ............................ 24,598 

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] 

BILLING CODE 4163–18–P 

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 


rmajette on PROD1PC67 with NOTICES
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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