Agency Information Collection Activities: Submission for OMB Review; Comment Request, 38635-38636 [E9-18524]

Download as PDF 38635 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 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 Number of respondents Number of responses per respondent Average burden per response (in hours) Intake assessment ................................... Baseline Survey ....................................... Completion Survey ................................... Follow-up Survey 1 .................................. Follow-up Survey 2 .................................. 800 600 400 400 400 1 1 1 1 1 15/60 1 1 1 1 200 600 400 400 400 ................................................................... .................... .................... .................... 2000 Type of respondent Form name Middle and High School Students ............ Total ................................................... 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 mstockstill on DSKH9S0YB1PROD with NOTICES 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 VerDate Nov<24>2008 16:07 Aug 03, 2009 Jkt 217001 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Total burden (in hours) 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. E:\FR\FM\04AUN1.SGM 04AUN1 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 re- administered 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 Number of respondents Number of responses per respondent Phase 1 Primary Care Provider Survey ........................................................ Clinic Staff Survey .......................................................................... Patient Exit Survey ......................................................................... ......................................................................................................... Electronic data abstraction ............................................................. 150 270 1,800 4 4 1 600 1,080 1,800 6 4 24 Phase 1 Burden ....................................................................... 2,226 .................... 3,504 ...................... 1,300 Phase 2 Primary Care Provider Survey ........................................................ Clinic Staff Survey .......................................................................... Patient Exit Survey ......................................................................... Patient Eligibility Screener * ............................................................ Patient Baseline Survey * ............................................................... Retention Risk Screener ................................................................. Retention Specialist/Patient Navigator Encounter .......................... Contact/locator information ............................................................. Electronic data abstraction ............................................................. 150 270 1,800 3,000 1,800 1,200 12 1,200 6 2 2 1 1 1 4 300 4 4 300 540 1,800 3,000 1,800 4,800 3,600 4,800 24 0.167 0.167 0.033 0.083 0.50 0.25 0.017 0.083 40.0 50 90 60 249 900 1,200 61 398 960 Phase 2 ................................................................................... 8,238 .................... 20,664 ...................... 3,968 Total Burden ..................................................................... 11,664 .................... 24,168 ...................... 5,268 Type of form by phase Total responses Average burden per response (in hours) 0.167 0.167 0.033 40.0 Total burden (in hours) 100 180 60 960 * Only administered one time during the entire project period. mstockstill on DSKH9S0YB1PROD with NOTICES 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 VerDate Nov<24>2008 16:07 Aug 03, 2009 Jkt 217001 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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. E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38635-38636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18524]


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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 pre-intervention 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 semi-annually 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.

[[Page 38636]]

    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 re-
administered 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
----------------------------------------------------------------------------------------------------------------
                                                              Number of                   Average
                                                 Number of    responses      Total      burden per      Total
             Type of form by phase              respondents      per       responses   response (in   burden (in
                                                              respondent                  hours)        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
                                                          6            4           24        40.0            960
    Electronic data abstraction...............
                                               -----------------------------------------------------------------
        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               12          300        3,600         0.017           61
     Encounter................................
    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