26246 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 

Dated: May 26, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12669 Filed 5–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–0743] 

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 email 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 

Assessment and Monitoring of 

Breastfeeding-Related Maternity Care 

Practices in Intra-partum Care Facilities 

in the United States and Territories 

(OMB Control No. 0920–0743, Exp. 7/ 

31/2009)–Revision–National Center for 

Chronic Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Substantial evidence demonstrates the 

health benefits of breastfeeding. 

Breastfeeding mothers have lower risks 

of breast and ovarian cancers and type 

2 diabetes, and breastfeeding better 

protects infants against infections, 

chronic diseases like diabetes and 

obesity, and even childhood leukemia 

and sudden infant death syndrome 

(SIDS). However, the groups that are at 

higher risk for diabetes, obesity, and 

poor health overall persistently have the 

lowest breastfeeding rates. Public health 

priorities for the U.S. include increasing 

the overall rate of breastfeeding, and 

reducing variation in breastfeeding rates 

across population subgroups. 

The health care system is one of the 

most important and effective settings to 

improve breastfeeding. In 2007, CDC 

conducted the first national survey of 

Maternity Practices in Infant Nutrition 

and Care (known as the mPINC Survey) 

in health care facilities (hospitals and 

free-standing childbirth centers). The 

survey was designed to provide baseline 

information and to be repeated again in 

2009. It inquired about patient 

education and support for breastfeeding 

throughout the maternity stay as well as 

staff training and maternity care 

policies. Each responding organization 

received a customized Benchmark 

Report as well as other feedback to use 

in self-assessment and quality 

improvement activities. 

CDC proposes to repeat the mPINC in 

2009 using previously fielded questions 

and methodology. In addition to all 

facilities that participated in 2007, the 

2009 survey will include those that 

were invited but did not participate in 

2007 and any that are new since then. 

All birth centers and hospitals with ≥ 1 

registered maternity beds will be 

screened via a brief phone call to assess 

their eligibility, identify additional 

locations, and identify the appropriate 

point of contact. 

A major goal of the 2009 survey is to 

be fully responsive to respondents’ 

needs for information and technical 

assistance. CDC will again provide 

customized benchmark reports to 

respondents and document progress 

since 2007 on their quality 

improvement efforts. National and state 

reports will use de-identified data to 

describe incremental changes in 

practices and care processes over time at 

the facility, state, and national levels. 

Participation in the survey is 

voluntary, and responses may be 

submitted by mail or through a webbased system. There are no costs to 

respondents other than their time. The 

total estimated annualized burden hours 

are 1,686. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Hospitals ................................. Telephone Screening Interview for Hospitals ........................ 3,897 1 5/60 

2009 mPINC Survey for Hospitals ......................................... 2,568 1 30/60 

Birth Centers ........................... Telephone Screening Interview for Birth Centers .................. 192 1 5/60 

2009 mPINC Survey for Birth Centers ................................... 122 1 30/60 

Dated: May 26, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–12631 Filed 5–29–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-0920–09BS] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 26247 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Formative Evaluation and Message 

Testing to Inform the Development of 

Health Promotion Materials for the 

National Hemophilia Foundation’s 

Hemophilia and AIDS/HIV Network for 

the Dissemination of Information 

(HANDI)—NEW—National Center on 

Birth Defects and Developmental 

Disabilities (NCBDDD), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The Division of Blood Disorders, 

located within the National Center on 

Birth Defects and Developmental 

Disabilities, implements health 

promotion and wellness programs 

designed to prevent secondary 

conditions in people with bleeding and 

clotting disorders. These programs are 

carried out in partnership with 

community-based organizations on the 

national and local level. The division’s 

largest and longest standing cooperative 

agreement is held by the National 

Hemophilia Foundation (NHF). NHF, 

founded in 1948, has a long history of 

service through education, advocacy 

and research for people and families 

with hemophilia and other bleeding 

disorders. 

The Hemophilia and AIDS/HIV 

Network for the Dissemination of 

Information (HANDI) is NHF’s resource 

center which provides information, 

materials, and support to people with 

bleeding and clotting disorders. Over 

the past 17 years, HANDI’s resource 

collection has grown to meet the 

changing needs of the community. 

HANDI processes thousands of requests 

for information from a wide variety of 

individuals and organizations including 

NHF chapters, medical professionals, 

consumers and their families, and 

teachers and students conducting 

research. The types of information 

requested reflect a diversity of needs— 

topics include home care, orthopedics, 

physical therapy, rare factor 

deficiencies, psychosocial issues, blood 

safety, women’s health, and financial 

and insurance reimbursement issues. 

HANDI’s current resource library 

collection contains nearly 13,000 items. 

However, the process by which 

materials have been selected for 

development has not been informed by 

a systematic needs assessment or other 

exploratory research. Therefore it is not 

known if the materials and messages 

that have been developed are meeting 

the information needs of the audiences 

they were intended to serve. 

While there seems to be many HANDI 

materials available that focus on parents 

and family members of newly diagnosed 

children, considerably less attention has 

been given to developing materials for 

young children and adolescents, 

particularly materials that address 

transition issues. There are many types 

of transitions for the person with a 

bleeding disorder. These include 

acceptance of the bleeding disorder, self 

care, progressing through school, 

vocational/career planning, moving to 

an adult center, starting a family, 

middle age, and retirement. Transition 

occurs throughout life for all people, but 

for those with chronic illness, it takes 

on additional significance due to the 

nature of their condition. 

The CDC’s Division of Blood 

Disorders in conjunction with the 

National Hemophilia Foundation will 

conduct focus groups to gather 

information that will be used to design 

educational materials and health 

promotion programs for young children 

(aged 5–12 years) and adolescents (aged 

16–19 years) that address transition 

issues. Focus groups will be used to 

explore the type of information, 

resources, and support young children 

and adolescents need related to 

transition issues. The groups will also 

be used to explore how young children 

and adolescents prefer to receive health 

messages and health information (e.g., 

brochures, videos, podcasts, U-tube, 

etc.). These findings will inform the 

development of key messages tailored to 

the target audiences that will then be 

tested during another set of focus groups 

to see how well the messages resonate 

with the intended end users. 

The Contractor selected will work 

with CDC and NHF, through its chapter 

network, to identify and recruit focus 

group participants. Formative research 

participants will include parents of 

young children (aged 5–12 years), 

parents of teenagers or young adults 

who can reflect back upon their 

experience and share what information, 

resources, and support they wished had 

been available when their child was 

young, and adolescents (aged 16–19 

years). Message testing participants will 

include parents of young children (aged 

5–12 years) and adolescents (aged 16–19 

years). Participants will be recruited to 

participate in one of sixteen in-person 

focus groups that will be conducted in 

the following cities: 

• Detroit, Atlanta, Philadelphia, San 

Francisco (for the formative research 

task), and 

• Milwaukee, Houston, Boston, and 

San Diego (for the message testing task) 

There are no costs to the respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Parents (formative groups) .............................................................................. 36 1 2 72 

Adolescents (formative groups) ....................................................................... 36 1 2 72 

Parents (message testing groups) .................................................................. 36 1 2 72 

Adolescents (message testing .........................................................................

groups) ............................................................................................................. 36 1 2 72 

Total .......................................................................................................... ........................ ........................ ........................ 288 

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