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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hours) 

Potential Participants ............................................................... Screener Contact Form ......... 550 1 10/60 

Intervention Participants—and Comparison Group) ............... Locator Form ......................... 330 1 3/60 

Intervention Participants—and Comparison Group ................ Assessment Baseline ............ 330 1 45/60 

Intervention Participants—and Comparison Group ................ Assessment Follow-up ........... 330 1 45/60 

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 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

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