Attachment 2 - 60 day FRN

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

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

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 [email protected]. 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

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

Hospitals .................................

Telephone Screening Interview for Hospitals ........................
2009 mPINC Survey for Hospitals .........................................
Telephone Screening Interview for Birth Centers ..................
2009 mPINC Survey for Birth Centers ...................................

Birth Centers ...........................

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

Number of
respondents

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

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3,897
2,568
192
122

Number of
responses per
respondent
1
1
1
1

Average
burden per
response
(in hours)
5/60
30/60
5/60
30/60

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
[email protected].
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

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26247

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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
(in hours)

Parents (formative groups) ..............................................................................
Adolescents (formative groups) .......................................................................
Parents (message testing groups) ..................................................................
Adolescents (message testing .........................................................................
groups) .............................................................................................................

36
36
36

1
1
1

2
2
2

72
72
72

36

1

2

72

Total ..........................................................................................................

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

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

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

288

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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 [email protected]. 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:

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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

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