Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38635 

to complete the survey and two-followup assessments. Therefore, over three 

years 2400 students will undergo an 

intake assessment, of whom we will 

recruit 1800 students into the study (300 

per year from intervention schools and 

300 per year from control schools), of 

whom we anticipate 1200 will have 

complete data. 

There is no cost to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Middle and High School Students ............ Intake assessment ................................... 800 1 15/60 200 

Baseline Survey ....................................... 600 1 1 600 

Completion Survey ................................... 400 1 1 400 

Follow-up Survey 1 .................................. 400 1 1 400 

Follow-up Survey 2 .................................. 400 1 1 400 

Total ................................................... ................................................................... .................... .................... .................... 2000 

Dated: July 24, 2009. 

Marilyn S Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–18604 Filed 8–3–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the OMB for review under 

the Paperwork Reduction Act of 1995: 

Proposed Project: Intervention Trials 

To Retain HIV-Positive Patients in 

Medical Care: (New) 

The purpose of this project is to 

develop, implement, and test the 

efficacy of an intervention designed to 

increase client appointment attendance 

among patients at risk of missing 

scheduled appointments at HIV clinics. 

This project is a collaboration between 

the Centers for Disease Control and 

Prevention (CDC), the Health Resources 

and Services Administration (HRSA), 

and six university-affiliated HIV clinics 

in the United States. The proposed 

intervention will be implemented in 

two phases. Phase 1 is a clinic-wide 

intervention that includes the following 

components: a theme slogan for the 

intervention, brochures, posters with 

messages to patients, brief verbal 

retention in care messages from 

providers to patients, buttons printed 

with the theme of the intervention worn 

by providers, and appointment 

reminder cards with information on 

how to cancel appointments. All clinic 

patients will receive the Phase 1 

intervention. Phase 2 of the project is a 

three-arm randomized trial in which 

300 patients in each of the six 

participating sites will be enrolled and 

randomly assigned to one of three study 

arms. In Arm 1 (control arm), patients 

(n=100) will receive the clinic-wide 

intervention only. Patients (n=100) 

assigned to Arm 2 (intervention arm) 

will continue to receive the clinic-wide 

intervention plus a comprehensive 

client-centered intervention from two 

trained interventionists. The remaining 

100 patients will be assigned to Arm 3 

and will receive the clinic-wide 

intervention plus a brief client-centered 

intervention. 

The efficacy of the intervention will 

be assessed through data collection 

efforts tailored to each phase of the 

intervention. Phase 1 uses a pre-post 

comparison of clinic attendance rates 

before and during a clinic-wide 

intervention. Specifically, in Phase 1, 

the attendance rate for HIV primary care 

is currently being assessed via 

electronic medical records during the 

12-month period before the clinic-wide 

intervention begins. This preintervention assessment is being 

collected for all patients who had at 

least one HIV primary care visit at the 

clinic during the preceding 12 months. 

This cohort of patients will be 

reassessed via electronic medical 

records during the 12-month 

intervention period. In addition, 

provider surveys will be administered 

quarterly during Phase 1 and semiannually during Phase 2 to obtain 

information from primary care providers 

(MD, DO, nurse practitioner, physician 

assistant) about whether they talked to 

their patients about the importance of 

regular care. Patient exit interviews will 

be administered every other month to 

assess patient exposure to the theme 

slogan for the intervention and posters 

with messages to patients as well as 

receipt of brochures and brief verbal 

retention in care messages from 

clinicians and clinic staff that comprise 

the Phase 1 intervention. 

In Phase 2, participants will be 

enrolled over a period of 4–9 months to 

allow flexibility for faster or slower 

enrollment in the clinics. It is 

anticipated that most clinics will 

complete their enrollment in 

approximately 6 months. On a daily 

basis, clinic staff or the study 

coordinator will generate a list of 

patients who meet eligibility criteria 

based on attendance history. The list 

will be given to the study coordinator 

who will approach patients to ask about 

their interest in being screened for 

eligibility in the study. When patients 

agree to be screened for eligibility, the 

study coordinator will administer an 

eligibility screener. Patients who are 

found to be eligible will be enrolled in 

the project and all enrollees will 

complete a baseline survey (that will 

take approximately 30 minutes) before 

being randomized to one of the two 

intervention arms or the control arm. No 

follow-up surveys will be collected. The 

survey will be administered in a private 

setting at the clinic using Audio 

Computer-Assisted Self-Interview 

(ACASI) in which respondents can read 

and listen via earphones to survey 

questions presented on the computer 

screen and respond directly into the 

computer. 

mstockstill on DSKH9S0YB1PROD with NOTICES

38636 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

Participants randomly assigned into 

the intervention arms will receive 

comprehensive or brief interventional 

services from two trained 

interventionists. The interventions will 

be delivered in face-to-face encounters 

as well as over the telephone and the 

first dose of the intervention will be 

delivered on the day the participant is 

enrolled into study. During the first 

face-to-face encounter, an 

interventionist will administer a 

retention risk screener. This screener is 

a clinical tool that will help identify 

attitudes, barriers, and unmet needs that 

might prevent a patient from staying in 

care. The screener contains three 

sections: (1) Attitudes and beliefs about 

HIV care and treatment, (2) barriers to 

consistent clinic attendance (e.g., 

transportation, child care, housing 

instability, scheduling problems, and 

lack of social support), and (3) recent 

drug/alcohol use and mental health. The 

information obtained from the risk 

screener will be used to tailor the 

interventions to each individual 

patient’s needs. Because a patient’s 

situation or needs may change over 

time, the screener will be readministered to intervention arm 

participants at a minimum every 3–4 

months during a clinic visit or other 

arranged face-to-face meetings outside 

of the clinic. In addition, the study 

coordinator will obtain contact/locator 

information for all participants enrolled 

in the intervention arm. Contact 

information will be updated as 

necessary by the intervention staff. 

The response burden for the six 

participating sites and patients enrolled 

in the study is estimated as: 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of form by phase Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

responses 

Average burden per 

response 

(in hours) 

Total burden 

(in hours) 

Phase 1 

Primary Care Provider Survey ........................................................ 150 4 600 0 .167 100 

Clinic Staff Survey .......................................................................... 270 4 1,080 0 .167 180 

Patient Exit Survey ......................................................................... 1,800 1 1,800 0 .033 60 

.........................................................................................................

Electronic data abstraction ............................................................. 6 4 24 40 .0 960 

Phase 1 Burden ....................................................................... 2,226 .................... 3,504 ...................... 1,300 

Phase 2 

Primary Care Provider Survey ........................................................ 150 2 300 0 .167 50 

Clinic Staff Survey .......................................................................... 270 2 540 0 .167 90 

Patient Exit Survey ......................................................................... 1,800 1 1,800 0 .033 60 

Patient Eligibility Screener * ............................................................ 3,000 1 3,000 0 .083 249 

Patient Baseline Survey * ............................................................... 1,800 1 1,800 0 .50 900 

Retention Risk Screener ................................................................. 1,200 4 4,800 0 .25 1,200 

Retention Specialist/Patient Navigator Encounter .......................... 12 300 3,600 0 .017 61 

Contact/locator information ............................................................. 1,200 4 4,800 0 .083 398 

Electronic data abstraction ............................................................. 6 4 24 40 .0 960 

Phase 2 ................................................................................... 8,238 .................... 20,664 ...................... 3,968 

Total Burden ..................................................................... 11,664 .................... 24,168 ...................... 5,268 

* Only administered one time during the entire project period. 

Written comments and 

recommendations concerning this 

proposed information collection should 

be sent within 30 days of this notice to: 

Office of Management and Budget, 

Office of Regulatory Affairs, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for HRSA. 

Dated: July 27, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–18524 Filed 8–3–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0277] 

Authorization of Emergency Use of 

Certain In Vitro Diagnostic Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of two Emergency Use 

Authorizations (EUAs) (the 

Authorizations), one of which was 

amended, for certain in vitro diagnostic 

devices. FDA is issuing the 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (the act), as 

requested by the Centers for Disease 

Control and Prevention (CDC). The 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized in vitro diagnostics. 

The Authorizations follow the 

determination by the Acting Secretary of 

the Department of Health and Human 

Services, Charles E. Johnson (the Acting 

Secretary), that a public health 

emergency exists involving Swine 

Influenza A (now known as 2009 H1N1 

Influenza A or 2009 H1N1 flu) that 

affects, or has the significant potential to 

affect, national security. On the basis of 

such determination, the Acting 

Secretary declared an emergency 

justifying the authorization of the 

emergency use of certain in vitro 

diagnostics, accompanied by emergency 

use information subject to the terms of 

any authorization issued under the act. 

mstockstill on DSKH9S0YB1PROD with NOTICES