B - 60 day FRN

Federal Register / Vol. 78, No. 44 / Wednesday, March 6, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–13–13LD]

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 404–639–7570 and
send comments to Ron Otten, at 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email 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
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.

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Proposed Project
Formative Research, Messages and
Materials Development for Birth Defects
and Developmental Disabilities, Human
Development and Disabilities, and
Blood Disorders—NEW—Centers for
Disease Control and Prevention (CDC),
National Center on Birth Defects and
Developmental Disabilities (NCBDDD).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), requests
approval for a new generic information
collection package that supports
formative research in birth defects and
developmental disabilities; human
development and disabilities, and blood
disorders. Identified priority diseases,
disorders, and conditions included in
this information collection activity
include but are not limited to

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preconception health; autism spectrum
disorders (ASDs) and other
developmental disabilities; fetal alcohol
spectrum disorders (FASDs); neural
tube defects (spina bifida, anencephaly);
muscular dystrophy; fragile X; deep
vein thrombosis/pulmonary embolism
(DVT/PE); sickle cell disease (SCD);
attention-deficit/hyperactivity disorder
(ADHD); and Tourette syndrome.
The Children’s Health Act of 2000
required the establishment of NCBDDD.
The Center is organized into three
divisions, which are focused on birth
defects and developmental disabilities,
human development and disabilities,
and blood disorders. NCBDDD promotes
the health of babies, children and adults
and focuses on identifying the causes of
and prevention of birth defects and
developmental disabilities; helping
children to develop and reach their
potential for full, productive living; and
optimizing the health outcomes among
people of all ages with disabilities.
These goals are accomplished through
research, partnerships, and prevention
and education programs.
Birth defects affect 1 in 33 babies and
are a leading cause of infant death in the
United States. More than 5,500 infants
die each year due to birth defects.
Additionally, over 500,000 children are
diagnosed with a developmental
disability. With more information, the
causes of these birth defects and
developmental disabilities can be
identified and action can be taken to
protect children and to develop new
ways to help women have healthy
babies.
Disabilities can affect anyone of any
age. About 1 in 5 Americans report
having some level of disability. People
with disabilities need health care and
health programs to stay well, active, and
a part of the community. To be healthy,
people with disabilities require health
care that meets their needs as a whole
person, not just as a person with a
disability.
Blood disorders such as sickle cell
disease, anemia, and hemophilia—affect
millions of people each year in the
United States, cutting across the
boundaries of age, race, sex, and
socioeconomic status. Men, women, and
children of all backgrounds live with
the complications associated with these
conditions, many of which are painful
and potentially life-threatening. With
proper preventive actions and early
intervention, many of these disorders
and their complications could, to a large
extent, be eliminated. NCBDDD is
dedicated to reducing the public health
burden resulting from these conditions
by contributing to a better
understanding of blood disorders and

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their complications; ensuring that
prevention programs are developed,
implemented, and evaluated; ensuring
that information is accessible to
consumers and health care providers;
and encouraging action to improve the
quality of life for people living with or
affected by these conditions.
The behavioral, clinical, and
surveillance projects implemented by
NCBDDD are the foundation upon
which recommendations and guidelines
are revised and updated. Formative
research is the mechanism by which
evidence is obtained for priority
diseases in these three (3) health
condition groups and by which
recommendations and guidelines are
revised and updated.
NCBDDD conducts formative research
for developing new messages, materials,
and strategies that respond to the
changing epidemiology of these priority
health conditions. A generic clearance
mechanism would increase productivity
of CDC programs and improve the
quality of public health interventions
and health communication programs.
The data collection and evidence are
developed using a multitude of
information sources including internal
and external subject matter experts,
field experience, consultation with
external colleagues, piloting activities,
and formal evaluations. The
involvement of external and internal
subject matter experts produces
scientifically valid instruments,
interventions, and methods that enable
NCBDDD to be responsive to the
changing epidemiology and community
needs of these priority diseases.
Targeted audience members or
representatives provide the information
for developing clear and influential
health messages, materials, and
strategies that promote health and wellbeing. An integrated research effort is
needed to fill in gaps of knowledge,
awareness, screening, and prevention
behaviors and could simultaneously
work to reduce stigma surrounding
these topics within special populations,
explore cultural issues, and increase the
demand for, and uptake of screening by
health care providers.
Overall, these formative research
activities are intended to provide
information that will increase the
success of the surveillance or research
project through increasing response
rates and decreasing response error
thereby decreasing future data
collection burden to the public.
This request is submitted to obtain
OMB clearance for three years. The
estimates of annualized burden hours
are based on past experience with
recruitment and the administration of

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Federal Register / Vol. 78, No. 44 / Wednesday, March 6, 2013 / Notices

similar surveys and focus groups. It is
estimated that 80,500 respondents will
have to be screened annually to recruit
the appropriate number of respondents

for this data collection activity. Specific
information will be provided with each
individual project submission. The
estimated annualized burden hours for

this data collection activity is 49,667.
There is no cost to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
General
General
General
General

public
public
public
public

and
and
and
and

health
health
health
health

care
care
care
care

Number of
respondents

Form name

providers
providers
providers
providers

Number of
responses per
respondent

Average hours
per response

Total response
burden
(hours)

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

Screener .......................
Consent Forms .............
Moderator’s Guide ........
Surveys .........................

80,500
30,000
30,000
15,000

1
1
1
1

10/60
5/60
1
15/60

13,417
2,500
30,000
3,750

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

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

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

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

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

49,667

Dated: February 28, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.

comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project

[FR Doc. 2013–05236 Filed 3–5–13; 8:45 am]

Formative Research for the
Development of CDC’s Act Against
AIDS Social Marketing Campaigns
Targeting Consumers—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-13–12EX]

Background and Brief Description

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) 639–7570 or send an
email to [email protected]. Send written

The purpose of this study is to
conduct interviews and focus groups in
four rounds of data collections
(exploratory research, message testing,
concept testing, materials testing) with
consumer groups aged 18 to 64 over a
3-year period to develop various social
marketing campaigns aimed at
increasing HIV testing rates, increasing
HIV awareness and knowledge,
challenging commonly held
misperceptions about HIV, and

promoting HIV prevention and risk
reduction.
The research results will be used to
develop materials for six specific HIV
social marketing campaigns under the
umbrella of the larger Act Against AIDS
campaign. The campaigns will target
consumers aged 18–64. Some campaigns
will target the general public as a whole
and other campaigns will focus on
specific subpopulations at greatest risk
for HIV infection. The target audiences
will include Latinos, men who have sex
with men (MSM), HIV-positive
individuals and African Americans.
The study will screen 2338 people per
year for eligibility. Of the 2,338 people
screened, it is expected that 500 people
will participate in focus groups, 500
people will participate in in-depth
interviews and 700 will participate in
intercept interviews. All focus group
and in-depth interview participants
(total 1000) will complete a brief paper
and pencil survey.
There are no costs to the respondents
other than their time.
The total estimated annual burden
hours are 2,311.

ESTIMATED ANNUALIZED BURDEN HOURS
Respondents

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Individuals (males
aged 18–64.

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and

Number of
respondents

Form name

females)

15:01 Mar 05, 2013

Screening Instrument ....................................................
In-depth interview focus group and intercept interview
Exploratory—HIV Testing In-depth Interview Guide .....
Exploratory—HIV Prevention In-depth Interview Guide
Exploratory—HIV Communication and Awareness Indepth Interview Guide.
Exploratory—HIV Prevention with Positives In-depth
Interview Guide.
Consumer Message Testing In-depth Interview Guide
Consumer Concept Testing In-depth Interview Guide
Consumer Materials Testing In-depth Interview Guide
Exploratory—HIV Testing Focus Group Interview
Guide.
Exploratory—HIV Prevention Focus Group Interview
Guide.

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Number of
responses per
respondent

Average
burden per
response
(in Hours)

2338

1

2/60

74
74
74

1
1
1

1
1
1

74

1

1

68
68
68
74

1
1
1
1

1
1
1
2

74

1

2

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