Agency Forms Undergoing Paperwork Reduction Act Review, 26248 [E9-12622]

Download as PDF 26248 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices Dated: May 26, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–12630 Filed 5–29–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–09–05CS] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395–6974. Written comments should be received within 30 days of this notice. Proposed Project Nurse Delivered Risk Reduction Intervention for HIV-Positive Women— New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC). Background and Brief Description During the past two decades, HIV surveillance data indicates an increase in HIV/AIDS cases among women in the non-urban Southeastern United States. In 2006, the majority of HIV/AIDS cases (80%) among women were attributed to high-risk heterosexual contact with an infected partner. Black women in particular have been disproportionately impacted by HIV/AIDS. Factors shown to be associated with HIV in the South include poverty, lack of access to medical care, poor education, lack of awareness of the disease, and exposure to other sexually transmitted diseases. Presently, there is an urgent need for enhanced HIV transmission prevention interventions for HIV positive women in the southeastern United States. The purpose of this project is to adapt and test the efficacy of an HIV transmission prevention intervention for reducing sexual risk among 330 HIVpositive women in North Carolina and to identify factors associated with risk among women. The study will be conducted in two parts (intervention trial and individual in-depth interviews). The intervention trial will evaluate a brief, nurse delivered, single session intervention. The trial will use a randomized wait-list comparison design with a three-month follow-up assessment. To determine eligibility for participation in the study, a brief, inperson, screening will be used. Eligible participants will complete baseline and follow-up behavioral assessments. The assessments contain questions about participants’ background, health and health care, sexual activity, substance use, and other psychosocial issues. The in-depth interviews will be conducted with a subgroup of 25–30 women. The purpose of the in-depth interviews is to assess experiences with the intervention, elicit recommendations for developing risk reduction intervention strategies, and to better understand the factors that place women at risk for HIV. Study participants will be recruited from health departments and clinics providing healthcare to HIV-positive women and AIDS Service Organizations. There is no cost to the participants other than their time. The total estimated annual burden hours are 635. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Potential Participants ............................................................... Intervention Participants—and Comparison Group) ............... Intervention Participants—and Comparison Group ................ Intervention Participants—and Comparison Group ................ Subset of Intervention Group .................................................. Screener Contact Form ......... Locator Form ......................... Assessment Baseline ............ Assessment Follow-up ........... In-depth Interview .................. Dated: May 26, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–12622 Filed 5–29–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–N–0464] (formerly Docket No. 2005N–0403) Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— SUMMARY: VerDate Nov<24>2008 16:53 May 29, 2009 Jkt 217001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 550 330 330 330 30 Number of responses per respondent 1 1 1 1 1 Avg. burden per response (in hours) 10/60 3/60 45/60 45/60 1 Drug Establishment Registration and Drug Listing.’’ This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing information. Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive. DATES: Submit written or electronic comments on agency guidances at any time. As of June 1, 2009, FDA will only accept electronic submissions of drug establishment registration and drug E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 74, Number 103 (Monday, June 1, 2009)]
[Notices]
[Page 26248]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-09-05CS]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Nurse Delivered Risk Reduction Intervention for HIV-Positive 
Women--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    During the past two decades, HIV surveillance data indicates an 
increase in HIV/AIDS cases among women in the non-urban Southeastern 
United States. In 2006, the majority of HIV/AIDS cases (80%) among 
women were attributed to high-risk heterosexual contact with an 
infected partner. Black women in particular have been 
disproportionately impacted by HIV/AIDS. Factors shown to be associated 
with HIV in the South include poverty, lack of access to medical care, 
poor education, lack of awareness of the disease, and exposure to other 
sexually transmitted diseases. Presently, there is an urgent need for 
enhanced HIV transmission prevention interventions for HIV positive 
women in the southeastern United States.
    The purpose of this project is to adapt and test the efficacy of an 
HIV transmission prevention intervention for reducing sexual risk among 
330 HIV-positive women in North Carolina and to identify factors 
associated with risk among women. The study will be conducted in two 
parts (intervention trial and individual in-depth interviews). The 
intervention trial will evaluate a brief, nurse delivered, single 
session intervention. The trial will use a randomized wait-list 
comparison design with a three-month follow-up assessment. To determine 
eligibility for participation in the study, a brief, in-person, 
screening will be used. Eligible participants will complete baseline 
and follow-up behavioral assessments. The assessments contain questions 
about participants' background, health and health care, sexual 
activity, substance use, and other psychosocial issues. The in-depth 
interviews will be conducted with a subgroup of 25-30 women. The 
purpose of the in-depth interviews is to assess experiences with the 
intervention, elicit recommendations for developing risk reduction 
intervention strategies, and to better understand the factors that 
place women at risk for HIV. Study participants will be recruited from 
health departments and clinics providing healthcare to HIV-positive 
women and AIDS Service Organizations. There is no cost to the 
participants other than their time. The total estimated annual burden 
hours are 635.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of      Avg. burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Potential Participants................  Screener Contact Form...             550               1           10/60
Intervention Participants--and          Locator Form............             330               1            3/60
 Comparison Group).
Intervention Participants--and          Assessment Baseline.....             330               1           45/60
 Comparison Group.
Intervention Participants--and          Assessment Follow-up....             330               1           45/60
 Comparison Group.
Subset of Intervention Group..........  In-depth Interview......              30               1               1
----------------------------------------------------------------------------------------------------------------


    Dated: May 26, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E9-12622 Filed 5-29-09; 8:45 am]
BILLING CODE 4163-18-P
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